The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Avl Hinge Knee System.
| Device ID | K051570 |
| 510k Number | K051570 |
| Device Name: | AVL HINGE KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-14 |
| Decision Date | 2005-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304554665 | K051570 | 000 |
| 00880304456198 | K051570 | 000 |
| 00880304456181 | K051570 | 000 |
| 00880304456174 | K051570 | 000 |
| 00880304456167 | K051570 | 000 |
| 00880304456150 | K051570 | 000 |
| 00880304456143 | K051570 | 000 |
| 00880304456136 | K051570 | 000 |
| 00880304456129 | K051570 | 000 |
| 00880304456204 | K051570 | 000 |
| 00880304456228 | K051570 | 000 |
| 00880304456235 | K051570 | 000 |
| 00880304554658 | K051570 | 000 |
| 00880304457836 | K051570 | 000 |
| 00880304457423 | K051570 | 000 |
| 00880304457300 | K051570 | 000 |
| 00880304456914 | K051570 | 000 |
| 00880304456266 | K051570 | 000 |
| 00880304456259 | K051570 | 000 |
| 00880304456242 | K051570 | 000 |
| 00880304202689 | K051570 | 000 |