The following data is part of a premarket notification filed by Integra Lifescience Corportation with the FDA for Integra Mozaik Osteoconductive Scaffold - Strip.
| Device ID | K141841 |
| 510k Number | K141841 |
| Device Name: | INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | INTEGRA LIFESCIENCE CORPORTATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Nicole C Harlan |
| Correspondent | Nicole C Harlan INTEGRA LIFESCIENCE CORPORTATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-08 |
| Decision Date | 2014-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M386560100501 | K141841 | 000 |
| M386CCM101551 | K141841 | 000 |