The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Prime And Dynasty® Additive Manufacturing Shells.
| Device ID | K202705 |
| 510k Number | K202705 |
| Device Name: | Prime And DYNASTY® Additive Manufacturing Shells |
| Classification | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented |
| Applicant | MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Contact | Gillen Gonzales |
| Correspondent | Gillen Gonzales MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Product Code | OQG |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-16 |
| Decision Date | 2021-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M684P3SAQG681 | K202705 | 000 |
| M684P3SAQA441 | K202705 | 000 |
| M684P3SAQB461 | K202705 | 000 |
| M684P3SAQB481 | K202705 | 000 |
| M684P3SAQC501 | K202705 | 000 |
| M684P3SAQC521 | K202705 | 000 |
| M684P3SAQD541 | K202705 | 000 |
| M684P3SAQD561 | K202705 | 000 |
| M684P3SAQE581 | K202705 | 000 |
| M684P3SAQE601 | K202705 | 000 |
| M684P3SAQF621 | K202705 | 000 |
| M684P3SAQF641 | K202705 | 000 |
| M684P3SAQG661 | K202705 | 000 |
| M684P3SAQA421 | K202705 | 000 |