The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Camber Spine Technologies Tls 5.0 Inerbody Cage.
| Device ID | K121254 |
| 510k Number | K121254 |
| Device Name: | CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | CAMBER SPINE TECHNOLOGIES 401 YANKEE COURT Newtown Square, PA 19073 |
| Contact | Dan Pontecorvo |
| Correspondent | Dan Pontecorvo CAMBER SPINE TECHNOLOGIES 401 YANKEE COURT Newtown Square, PA 19073 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-25 |
| Decision Date | 2013-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B030CK2212070 | K121254 | 000 |
| B030CK2412130 | K121254 | 000 |
| B030CK2412140 | K121254 | 000 |
| B030CK2412150 | K121254 | 000 |
| B030CK2810070 | K121254 | 000 |
| B030CK2810080 | K121254 | 000 |
| B030CK2810090 | K121254 | 000 |
| B030CK2810100 | K121254 | 000 |
| B030CK2810110 | K121254 | 000 |
| B030CK2810120 | K121254 | 000 |
| B030CK2810130 | K121254 | 000 |
| B030CK2810140 | K121254 | 000 |
| B030CK2412120 | K121254 | 000 |
| B030CK2412110 | K121254 | 000 |
| B030CK2412100 | K121254 | 000 |
| B030CK2212080 | K121254 | 000 |
| B030CK2212090 | K121254 | 000 |
| B030CK2212100 | K121254 | 000 |
| B030CK2212110 | K121254 | 000 |
| B030CK2212120 | K121254 | 000 |
| B030CK2212130 | K121254 | 000 |
| B030CK2212140 | K121254 | 000 |
| B030CK2212150 | K121254 | 000 |
| B030CK2412070 | K121254 | 000 |
| B030CK2412080 | K121254 | 000 |
| B030CK2412090 | K121254 | 000 |
| B030CK2810150 | K121254 | 000 |
| B030CX2210070 | K121254 | 000 |
| B030CX2610130 | K121254 | 000 |
| B030CX2610140 | K121254 | 000 |
| B030CX2610150 | K121254 | 000 |
| B030CX3010070 | K121254 | 000 |
| B030CX3010080 | K121254 | 000 |
| B030CX3010090 | K121254 | 000 |
| B030CX3010100 | K121254 | 000 |
| B030CX3010110 | K121254 | 000 |
| B030CX3010120 | K121254 | 000 |
| B030CX3010130 | K121254 | 000 |
| B030CX3010140 | K121254 | 000 |
| B030CX2610120 | K121254 | 000 |
| B030CX2610110 | K121254 | 000 |
| B030CX2610100 | K121254 | 000 |
| B030CX2210080 | K121254 | 000 |
| B030CX2210090 | K121254 | 000 |
| B030CX2210100 | K121254 | 000 |
| B030CX2210110 | K121254 | 000 |
| B030CX2210120 | K121254 | 000 |
| B030CX2210130 | K121254 | 000 |
| B030CX2210140 | K121254 | 000 |
| B030CX2210150 | K121254 | 000 |
| B030CX2610070 | K121254 | 000 |
| B030CX2610080 | K121254 | 000 |
| B030CX2610090 | K121254 | 000 |
| B030CX3010150 | K121254 | 000 |