The following data is part of a premarket notification filed by Global Medical Co. with the FDA for Global Press-fit Stem.
| Device ID | K032385 |
| 510k Number | K032385 |
| Device Name: | GLOBAL PRESS-FIT STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | GLOBAL MEDICAL CO. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb GLOBAL MEDICAL CO. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2003-10-30 |
| Summary: | summary |