The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Global Shoulder Crosslink Glenoid.
| Device ID | K052472 |
| 510k Number | K052472 |
| Device Name: | DEPUY GLOBAL SHOULDER CROSSLINK GLENOID |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Natalie Heck |
| Correspondent | Natalie Heck DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-08 |
| Decision Date | 2005-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295007494 | K052472 | 000 |
| 10603295006978 | K052472 | 000 |
| 10603295006992 | K052472 | 000 |
| 10603295007012 | K052472 | 000 |
| 10603295007036 | K052472 | 000 |
| 10603295007340 | K052472 | 000 |
| 10603295007371 | K052472 | 000 |
| 10603295007401 | K052472 | 000 |
| 10603295007432 | K052472 | 000 |
| 10603295007463 | K052472 | 000 |
| 10603295006954 | K052472 | 000 |