The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Comprehensive Humeral Fracture Positioning Sleeve.
| Device ID | K033506 |
| 510k Number | K033506 |
| Device Name: | COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-05 |
| Decision Date | 2004-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304213159 | K033506 | 000 |
| 00880304213050 | K033506 | 000 |
| 00880304213067 | K033506 | 000 |
| 00880304213074 | K033506 | 000 |
| 00880304213081 | K033506 | 000 |
| 00880304213098 | K033506 | 000 |
| 00880304213104 | K033506 | 000 |
| 00880304213111 | K033506 | 000 |
| 00880304213128 | K033506 | 000 |
| 00880304213135 | K033506 | 000 |
| 00880304213142 | K033506 | 000 |
| 00880304213043 | K033506 | 000 |