The following data is part of a premarket notification filed by Safe Orthopaedics with the FDA for Sterispine Lc Cage.
| Device ID | K122021 |
| 510k Number | K122021 |
| Device Name: | STERISPINE LC CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SAFE ORTHOPAEDICS PARC DES BELLEVUES- ALLEE R LUXEMBOURG Eragny Sur Oise, FR 95610 |
| Contact | P. Dumouchel |
| Correspondent | P. Dumouchel SAFE ORTHOPAEDICS PARC DES BELLEVUES- ALLEE R LUXEMBOURG Eragny Sur Oise, FR 95610 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-10 |
| Decision Date | 2012-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760219910343 | K122021 | 000 |