K233640
- 510(k) number
- K233640
- Device name
- Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System
- Applicant
- Alphatec Spine, Inc. CA · US
- Product code
- KWQ — Appliance, Fixation, Spinal Intervertebral Body
- Decision date
- 2024-02-22
- Date received
- 2023-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K233640.pdf
Official FDA record: K233640
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.