The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensive Srs/nexel Elbow.
| Device ID | K153398 |
| 510k Number | K153398 |
| Device Name: | Comprehensive SRS/Nexel Elbow |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw, IN 46580 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw, IN 46580 |
| Product Code | JDC |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-24 |
| Decision Date | 2016-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304850415 | K153398 | 000 |
| 00880304806016 | K153398 | 000 |
| 00880304806023 | K153398 | 000 |
| 00880304806030 | K153398 | 000 |
| 00880304806047 | K153398 | 000 |
| 00880304806054 | K153398 | 000 |
| 00880304806085 | K153398 | 000 |
| 00880304806092 | K153398 | 000 |
| 00880304806108 | K153398 | 000 |
| 00880304806115 | K153398 | 000 |
| 00880304806122 | K153398 | 000 |
| 00880304806139 | K153398 | 000 |
| 00880304850361 | K153398 | 000 |
| 00880304850378 | K153398 | 000 |
| 00880304850385 | K153398 | 000 |
| 00880304850392 | K153398 | 000 |
| 00880304850408 | K153398 | 000 |
| 00880304806009 | K153398 | 000 |