K232822
- 510(k) number
- K232822
- Device name
- Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
- Applicant
- Gbs Commonwealth Co., Ltd. KR
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2023-10-13
- Date received
- 2023-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232822.pdf
Official FDA record: K232822
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.