The following data is part of a premarket notification filed by Global Manufacturing Technology with the FDA for Msa Hip System.
| Device ID | K102172 |
| 510k Number | K102172 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-02 |
| Decision Date | 2011-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348215087289 | K102172 | 000 |
| 09348215087180 | K102172 | 000 |
| 09348215087197 | K102172 | 000 |
| 09348215087203 | K102172 | 000 |
| 09348215087210 | K102172 | 000 |
| 09348215087227 | K102172 | 000 |
| 09348215087234 | K102172 | 000 |
| 09348215087241 | K102172 | 000 |
| 09348215087258 | K102172 | 000 |
| 09348215087265 | K102172 | 000 |
| 09348215087272 | K102172 | 000 |
| 09348215087173 | K102172 | 000 |