PROFEMUR® GLADIATOR® Cemented Classic Stem
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
MicroPort Orthopedics Inc.
The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Profemur® Gladiator® Cemented Classic Stem.
Pre-market Notification Details
| Device ID | K201519 |
| 510k Number | K201519 |
| Device Name: | PROFEMUR® GLADIATOR® Cemented Classic Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Contact | Kristen Russell |
| Correspondent | Allen Mamaril MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-08 |
| Decision Date | 2020-12-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M684PRGCME121 | K201519 | 000 |
| M684PRGCCMS61 | K201519 | 000 |
| M684PRGCCMS81 | K201519 | 000 |
| M684PRGCCME41 | K201519 | 000 |
| M684PRGCCME61 | K201519 | 000 |
| M684PRGCCME81 | K201519 | 000 |
| M684PRGCMS101 | K201519 | 000 |
| M684PRGCMS121 | K201519 | 000 |
| M684PRGCME101 | K201519 | 000 |
| M684PRGCCMS41 | K201519 | 000 |
Trademark Results [PROFEMUR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROFEMUR 76380670 2692765 Live/Registered |
Wright Medical Technology, Inc. 2002-03-11 |
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