The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Regenerex Porous Titanium Sleeve Augments.
| Device ID | K072336 |
| 510k Number | K072336 |
| Device Name: | REGENEREX POROUS TITANIUM SLEEVE AUGMENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Becky Earl |
| Correspondent | Becky Earl BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JWH |
| Subsequent Product Code | KRO |
| Subsequent Product Code | MBH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-20 |
| Decision Date | 2007-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304467088 | K072336 | 000 |
| 00887868252228 | K072336 | 000 |
| 00887868252235 | K072336 | 000 |
| 00887868252242 | K072336 | 000 |
| 00887868252259 | K072336 | 000 |
| 00887868252266 | K072336 | 000 |
| 00887868252273 | K072336 | 000 |
| 00887868252280 | K072336 | 000 |
| 00880304461925 | K072336 | 000 |
| 00880304461932 | K072336 | 000 |
| 00880304461949 | K072336 | 000 |
| 00880304461956 | K072336 | 000 |
| 00880304461963 | K072336 | 000 |
| 00880304461970 | K072336 | 000 |
| 00880304467057 | K072336 | 000 |
| 00887868252211 | K072336 | 000 |