The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Profemur Gladiator Thin Ha Classic Hip Stem With Collar.
| Device ID | K200007 |
| 510k Number | K200007 |
| Device Name: | PROFEMUR GLADIATOR Thin HA Classic Hip Stem With Collar |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Contact | Allen Mamaril |
| Correspondent | Allen Mamaril MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-02 |
| Decision Date | 2020-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M684PGHCCS101 | K200007 | 000 |
| M684PGHCCLS91 | K200007 | 000 |
| M684PGHCCLS81 | K200007 | 000 |
| M684PGHCCLS71 | K200007 | 000 |
| M684PGHCCLS61 | K200007 | 000 |
| M684PGHCCLS51 | K200007 | 000 |
| M684PGHCCLS41 | K200007 | 000 |
| M684PGHCCLS31 | K200007 | 000 |
| M684PGHCCLS21 | K200007 | 000 |
| M684PGHCCLE11 | K200007 | 000 |
| M684PGHCCLE21 | K200007 | 000 |
| M684PGHCCLE71 | K200007 | 000 |
| M684PGHCCE101 | K200007 | 000 |
| M684PGHCCLE91 | K200007 | 000 |
| M684PGHCCLE81 | K200007 | 000 |
| M684PGHCCLE61 | K200007 | 000 |
| M684PGHCCLE51 | K200007 | 000 |
| M684PGHCCLE41 | K200007 | 000 |
| M684PGHCCLE31 | K200007 | 000 |
| M684PGHCCLS11 | K200007 | 000 |