The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Aura Hip System Cemented Femoral Stem/cemented Long Femoral Stem.
| Device ID | K961304 |
| 510k Number | K961304 |
| Device Name: | AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Contact | Martha C Miller |
| Correspondent | Martha C Miller EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-04 |
| Decision Date | 1996-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862014122 | K961304 | 000 |
| 10885862015266 | K961304 | 000 |
| 10885862015259 | K961304 | 000 |
| 10885862015174 | K961304 | 000 |
| 10885862015167 | K961304 | 000 |
| 10885862015150 | K961304 | 000 |
| 10885862015143 | K961304 | 000 |
| 10885862015136 | K961304 | 000 |
| 10885862015129 | K961304 | 000 |
| 10885862015112 | K961304 | 000 |
| 10885862015211 | K961304 | 000 |
| 10885862015204 | K961304 | 000 |
| 10885862015198 | K961304 | 000 |
| 10885862015273 | K961304 | 000 |
| 10885862015280 | K961304 | 000 |
| 10885862015297 | K961304 | 000 |
| 10885862014115 | K961304 | 000 |
| 10885862014108 | K961304 | 000 |
| 10885862015570 | K961304 | 000 |
| 10885862015563 | K961304 | 000 |
| 10885862015556 | K961304 | 000 |
| 10885862015549 | K961304 | 000 |
| 10885862015358 | K961304 | 000 |
| 10885862015341 | K961304 | 000 |
| 10885862015334 | K961304 | 000 |
| 10885862015327 | K961304 | 000 |
| 10885862015310 | K961304 | 000 |
| 10885862015303 | K961304 | 000 |
| 10885862015181 | K961304 | 000 |