The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Global Fx Porous-coated Humeral Stem.
| Device ID | K011099 |
| 510k Number | K011099 |
| Device Name: | GLOBAL FX POROUS-COATED HUMERAL STEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | MBF |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-11 |
| Decision Date | 2001-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295005056 | K011099 | 000 |
| 10603295005025 | K011099 | 000 |
| 10603295004998 | K011099 | 000 |
| 10603295004967 | K011099 | 000 |