The following data is part of a premarket notification filed by Calvary Spine Llc with the FDA for Integra Cervical And Petra Plif Lumbar Cages.
| Device ID | K082260 |
| 510k Number | K082260 |
| Device Name: | INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | CALVARY SPINE LLC 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb CALVARY SPINE LLC 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-08 |
| Decision Date | 2008-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M696380000 | K082260 | 000 |
| M696300090 | K082260 | 000 |
| M696300100 | K082260 | 000 |
| M696300110 | K082260 | 000 |
| M696300120 | K082260 | 000 |
| M696300130 | K082260 | 000 |
| M696300140 | K082260 | 000 |
| M696300150 | K082260 | 000 |
| M696385000 | K082260 | 000 |
| M696390000 | K082260 | 000 |
| M696120000 | K082260 | 000 |
| M696120010 | K082260 | 000 |
| M696300080 | K082260 | 000 |
| M696300070 | K082260 | 000 |
| M696180000 | K082260 | 000 |
| M696186000 | K082260 | 000 |
| M696100070 | K082260 | 000 |
| M696100080 | K082260 | 000 |
| M696100090 | K082260 | 000 |
| M696100100 | K082260 | 000 |
| M696100110 | K082260 | 000 |
| M696100120 | K082260 | 000 |
| M696100130 | K082260 | 000 |
| M696100140 | K082260 | 000 |
| M696100150 | K082260 | 000 |
| B114100070 | K082260 | 000 |
| B114100080 | K082260 | 000 |
| B114100090 | K082260 | 000 |
| B114201070 | K082260 | 000 |
| B114201080 | K082260 | 000 |
| B114201090 | K082260 | 000 |
| B114300070 | K082260 | 000 |
| B114300080 | K082260 | 000 |
| B114300090 | K082260 | 000 |
| B114300100 | K082260 | 000 |
| B114300110 | K082260 | 000 |
| B114300120 | K082260 | 000 |
| B114300130 | K082260 | 000 |
| B114300140 | K082260 | 000 |
| B114201060 | K082260 | 000 |
| B114201050 | K082260 | 000 |
| B114100100 | K082260 | 000 |
| B114100110 | K082260 | 000 |
| B114100120 | K082260 | 000 |
| B114100130 | K082260 | 000 |
| B114100140 | K082260 | 000 |
| B114100150 | K082260 | 000 |
| B114200050 | K082260 | 000 |
| B114200060 | K082260 | 000 |
| B114200070 | K082260 | 000 |
| B114200080 | K082260 | 000 |
| B114200090 | K082260 | 000 |
| B114300150 | K082260 | 000 |