The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-series 12/14 Neck Segments.
| Device ID | K032964 |
| 510k Number | K032964 |
| Device Name: | EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Gary J Miller |
| Correspondent | Gary J Miller 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 | 2003-09-23 |
| Decision Date | 2003-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862025494 | K032964 | 000 |
| 10885862030849 | K032964 | 000 |
| 10885862010490 | K032964 | 000 |
| 10885862016850 | K032964 | 000 |
| 10885862038609 | K032964 | 000 |
| 10885862238641 | K032964 | 000 |
| 10885862238658 | K032964 | 000 |
| 10885862256607 | K032964 | 000 |
| 10885862553072 | K032964 | 000 |
| 10885862025395 | K032964 | 000 |
| 10885862025401 | K032964 | 000 |
| 10885862025432 | K032964 | 000 |
| 10885862025449 | K032964 | 000 |
| 10885862025456 | K032964 | 000 |
| 10885862629432 | K032964 | 000 |