The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Mozaik Bone Regeneration Matrix - Putty.
| Device ID | K062353 |
| 510k Number | K062353 |
| Device Name: | MOZAIK BONE REGENERATION MATRIX - PUTTY |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Diana M Bordon |
| Correspondent | Diana M Bordon INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-11 |
| Decision Date | 2006-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18257200115136 | K062353 | 000 |
| 10381780112044 | K062353 | 000 |
| M2697100151 | K062353 | 000 |
| M2697100101 | K062353 | 000 |
| M2697100051 | K062353 | 000 |
| 10889981123352 | K062353 | 000 |
| 10889981123345 | K062353 | 000 |
| 10889981123338 | K062353 | 000 |
| 10889981123321 | K062353 | 000 |
| 10889981123291 | K062353 | 000 |
| 10889981123284 | K062353 | 000 |
| 10889981123277 | K062353 | 000 |
| 10381780112051 | K062353 | 000 |
| 10381780112068 | K062353 | 000 |
| M269IOS101251 | K062353 | 000 |
| 18257200115129 | K062353 | 000 |
| 18257200115112 | K062353 | 000 |
| M386560701501 | K062353 | 000 |
| M386560701001 | K062353 | 000 |
| M386560700501 | K062353 | 000 |
| M386560700251 | K062353 | 000 |
| M386PTY102561 | K062353 | 000 |
| M386PTY102101 | K062353 | 000 |
| M386PTY101551 | K062353 | 000 |
| M386PTY101251 | K062353 | 000 |
| M269IOS101551 | K062353 | 000 |
| 10889981123260 | K062353 | 000 |