The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Novation Integrip Acetabular Augments, Groups 4 And 5.
| Device ID | K113609 |
| 510k Number | K113609 |
| Device Name: | NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Vladislava Zaitseva |
| Correspondent | Vladislava Zaitseva EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-06 |
| Decision Date | 2012-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862209382 | K113609 | 000 |
| 10885862209375 | K113609 | 000 |
| 10885862209368 | K113609 | 000 |
| 10885862209351 | K113609 | 000 |
| 10885862209344 | K113609 | 000 |
| 10885862209337 | K113609 | 000 |