The following data is part of a premarket notification filed by Orthopro Llc with the FDA for Metal Hemi Implant.
| Device ID | K071243 |
| 510k Number | K071243 |
| Device Name: | METAL HEMI IMPLANT |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | ORTHOPRO LLC 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb ORTHOPRO LLC 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-03 |
| Decision Date | 2007-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420168337 | K071243 | 000 |
| 00840420168320 | K071243 | 000 |
| 00840420168313 | K071243 | 000 |
| 00840420168306 | K071243 | 000 |