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 |