The following data is part of a premarket notification filed by Osteomed Lp with the FDA for Primalif Tm Llif Unitary Peek Lateral Lumbar Interbody Fusion System.
| Device ID | K123207 |
| 510k Number | K123207 |
| Device Name: | PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | OSTEOMED LP 3885 Arapaho Rd Addison, TX 75001 |
| Contact | Piedad Pena |
| Correspondent | Piedad Pena OSTEOMED LP 3885 Arapaho Rd Addison, TX 75001 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-12 |
| Decision Date | 2012-11-29 |
| Summary: | summary |