The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Microport Cocr Femoral Heads.
| Device ID | K190123 |
| 510k Number | K190123 |
| Device Name: | MicroPort CoCr Femoral Heads |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Contact | Tejas Patel |
| Correspondent | Tejas Patel MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-25 |
| Decision Date | 2019-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M684260136XXWD1 | K190123 | 000 |
| M68426010006WD1 | K190123 | 000 |
| M684260100111 | K190123 | 000 |
| M68426010011WD1 | K190123 | 000 |
| M684260136LG1 | K190123 | 000 |
| M684260136LGWD1 | K190123 | 000 |
| M684260136MD1 | K190123 | 000 |
| M684260136MDWD1 | K190123 | 000 |
| M684260136SH1 | K190123 | 000 |
| M684260136SHWD1 | K190123 | 000 |
| M684260136XL1 | K190123 | 000 |
| M684260136XLWD1 | K190123 | 000 |
| M684260136XS1 | K190123 | 000 |
| M684260136XSWD1 | K190123 | 000 |
| M684260136XX1 | K190123 | 000 |
| M684260100061 | K190123 | 000 |