The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Comprehensive Humeral Fracture System.
| Device ID | K023063 |
| 510k Number | K023063 |
| Device Name: | COMPREHENSIVE HUMERAL FRACTURE SYSTEM |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Dalene T Binkley |
| Correspondent | Dalene T Binkley BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWT |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-16 |
| Decision Date | 2002-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304441842 | K023063 | 000 |
| 00887868343810 | K023063 | 000 |
| 00887868343827 | K023063 | 000 |
| 00887868343834 | K023063 | 000 |
| 00887868343841 | K023063 | 000 |
| 00887868343858 | K023063 | 000 |
| 00880304430808 | K023063 | 000 |
| 00880304430907 | K023063 | 000 |
| 00880304430914 | K023063 | 000 |
| 00880304430921 | K023063 | 000 |
| 00880304431218 | K023063 | 000 |
| 00887868343803 | K023063 | 000 |