Orthopedic

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Code	Device name	Class	21 CFR	510(k) (3y)
NUD	Vertebroplasty Compound, Calcium Based	Class 2	21 CFR 888.3027
NVC	Bone, Heterograft	Class 3	21 CFR 888.3015
NWN	Laparoscopic Bone Anchor Urethropexy Instrument Kit	Class 2	21 CFR 888.3040
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Class 1	21 CFR 888.4200	1
OBL	Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty	Class 2	21 CFR 888.3027	1
OBM	Cement, Bone, Vertebroplasty, Pre-Formed, Modular	Class 2	21 CFR 888.3027
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Class 2	21 CFR 888.3030	6
OCG	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented	Class 3	21 CFR 888.3410
OCJ	Spinal Channeling Instrument, Vertebroplasty	Class 1	21 CFR 888.4540	1
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class 2	21 CFR 888.3080	354
OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	Class 2	21 CFR 888.3045	1
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Pol	Class 2	21 CFR 888.3560	12
OJB	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate	Class 2	21 CFR 888.3060	3
OJM	Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh	Class 2	21 CFR 888.3060
OOG	Knee Arthroplasty Implantation System	Class 2	21 CFR 888.3560	2
OOL	Electronic Depth Gauge	Class 2	21 CFR 888.3030	1
OQB	Intervertebral Body Graft Containment Device	Class 2	21 CFR 888.3085	4
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive,	Class 2	21 CFR 888.3358	20
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Class 2	21 CFR 888.3350
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Por	Class 2	21 CFR 888.3353	5
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class 2	21 CFR 888.3070	19
OSN	Software For Diagnosis/Treatment	Class 2	21 CFR 888.3030	4
OUR	Sacroiliac Joint Fixation	Class 2	21 CFR 888.3040	132
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class 2	21 CFR 888.3080	204
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class 2	21 CFR 888.3080	166
OVZ	Pin, Fixation, Resorbable, Hard Tissue	Class 2	21 CFR 888.3040	3
OWI	Bone Fixation Cerclage, Sublaminar	Class 2	21 CFR 888.3010	37
OYK	Ankle Arthroplasty Implantation System	Class 2	21 CFR 888.3110	7
OZI	Internal Hinged Elbow Fixator	Class 2	21 CFR 888.3030	3
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Ceme	Class 2	21 CFR 888.3660	1
PBF	Orthopaedic Surgical Planning And Instrument Guides	Class 2	21 CFR 888.3030	27
PBI	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, +	Class 2	21 CFR 888.3310	2
PEK	Spinous Process Plate	Class 2	21 CFR 888.3050	48
PGM	Growing Rod System	Class 2	21 CFR 888.3070	14
PGN	Growing Rod System- Magnetic Actuation	Class 2	21 CFR 888.3070	9
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Class 2	21 CFR 888.3080	3
PHQ	Anterior Staple As Supplemental Fixation For Fusion	Class 2	21 CFR 888.3060	2
PHX	Shoulder Prosthesis, Reverse Configuration	Class 2	21 CFR 888.3660	205
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral St	Class 2	21 CFR 888.3660	19
PLF	Bone Wedge	Class 2	21 CFR 888.3030	18
PLR	Spinal Vertebral Body Replacement Device - Cervical	Class 2	21 CFR 888.3060	19
PLW	Acetabular Cup Orientation System	Class 2	21 CFR 888.3350	1
PML	Bone Cement, Posterior Screw Augmentation	Class 2	21 CFR 888.3027	19
PPQ	Transtibial Anterior Cruciate Ligament Kit	Class 2	21 CFR 888.3040
PPR	Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures	Class 2	21 CFR 888.1100
PQC	Pedicle Screw Placement Guide	Class 2	21 CFR 888.3070	8
QAC	Screw Sleeve Bone Fixation Device	Class 2	21 CFR 888.3043	1
QAD	Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Ac	Class 2	21 CFR 888.3023	7
QBO	Instruments Designed For Press-Fit Osteochondral Implants	Class 2	21 CFR 888.4505	2
QFP	Intraoperative Orthopedic Strain Sensor	Class 2	21 CFR 888.3090	1
QGQ	Bone Indentation Device	Class 2	21 CFR 888.1600	3
QHE	Shoulder Arthroplasty Implantation System	Class 2	21 CFR 888.3660	26
QHG	Defect Measurement Tool	Class 2	21 CFR 888.4510	1
QHQ	Total Shoulder Arthroplasty System	Class 2	21 CFR 888.3660	1
QJD	Absorbable Metallic Bone Fixation Fastener	Class 2	21 CFR 888.3041	1
QKW	Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Ceme	Class 2	21 CFR 888.3695	1
QLQ	Manual Instruments Designed For Use With Total Disc Replacement Device	Class 2	21 CFR 888.4515	9
QLR	Manual Instruments Designed For Use With Non-Fusion Spinous Process Sp	Class 2	21 CFR 888.4520	1
QNI	Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair	Class 2	21 CFR 888.3044	3
QPP	Implantable Post-Surgical Kinematic Measurement Knee Device	Class 2	21 CFR 888.3600	4
QPQ	Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable,	Class 2	21 CFR 888.3630	1
QRR	Filler, Bone Void, Calcium Compound Containing Single Approved Aminogl	Class 2	21 CFR 888.3046	2
QSD	Posterior Cervical Screw Placement Guide	Class 2	21 CFR 888.3075	2
QSR	Sacroiliac Screw Placement Guide	Class 2	21 CFR 888.3040	1
QVI	Screw Sleeve Bone Fixation Device, Spine	Class 2	21 CFR 888.3043	2
QVL	Absorbable Gel For Intraoperative Use In Spine Surgery	Class 2	21 CFR 888.3047	2
QVV	Medial Knee Implanted Shock Absorber	Class 2	21 CFR 888.3610	1
QWL	Intraoperative Surgical Angle Measurement Tool	Class 2	21 CFR 888.4560	3
QZO	Wearable Vibration Device For Orthopedic Use	Class 2	21 CFR 888.5895	1
QZY	Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide	Class 2	21 CFR 888.3071	1
QZZ	Limb And Joint Salvage Device With Coating For Bacteria Reduction	Class 2	21 CFR 888.3900	3
SAI	Ankle Fusion Cage	Class 2	21 CFR 888.3020	2
SCY	Sacroiliac Joint Guidewire Placement Device	Class 2	21 CFR 888.3040	1
SGL	Manual Instruments Designed For Use With Non-Fusion Spinous Process Te	Class 2	21 CFR 888.4520	1
SIN	Automated Intraoperative Spinal Rod Bending System	Class 2	21 CFR 888.3070	1
SIQ	Intra-Articular Orthopedic Stereotaxic Navigation Instrument	Class 2	21 CFR 888.4561	1
SIT	Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality	Class 2	21 CFR 888.1150	1
SJA	Injectable For Thermal Treatment Of Musculoskeletal Pain	Class 2	21 CFR 888.3048	1