The following data is part of a premarket notification filed by Global Manufacturing Technology with the FDA for Msa Hip System.
| Device ID | K113107 |
| 510k Number | K113107 |
| Device Name: | MSA HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | GLOBAL MANUFACTURING TECHNOLOGY 1331 H STREET NW Washington, DC 20005 |
| Contact | Hollace S Rhodes |
| Correspondent | Hollace S Rhodes GLOBAL MANUFACTURING TECHNOLOGY 1331 H STREET NW Washington, DC 20005 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-20 |
| Decision Date | 2011-12-15 |
| Summary: | summary |