The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Integra Mozaik Bone Regeneration Matrix - Strips.
| Device ID | K063124 |
| 510k Number | K063124 |
| Device Name: | INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Diana M Bordon |
| Correspondent | Diana M Bordon INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE 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 | 2006-10-13 |
| Decision Date | 2007-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18257200121878 | K063124 | 000 |
| 10889981206161 | K063124 | 000 |
| 10889981123307 | K063124 | 000 |
| 10889981123314 | K063124 | 000 |
| 10889981123369 | K063124 | 000 |
| 10889981123376 | K063124 | 000 |
| M386CCM102101 | K063124 | 000 |
| M386CCM102561 | K063124 | 000 |
| 18257200121861 | K063124 | 000 |
| 10889981206154 | K063124 | 000 |