The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Signature Personalized Patient Care System - Glenoid Guide System.
| Device ID | K130126 |
| 510k Number | K130126 |
| Device Name: | SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy B Johnson |
| Correspondent | Tracy B Johnson BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBF |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | PAO |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-17 |
| Decision Date | 2013-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304567610 | K130126 | 000 |
| 00880304567603 | K130126 | 000 |
| 00880304539013 | K130126 | 000 |
| 00887868262166 | K130126 | 000 |
| 00887868262142 | K130126 | 000 |