The following data is part of a premarket notification filed by Orthopro Llc with the FDA for Orthropro Hemi Toe.
| Device ID | K062908 |
| 510k Number | K062908 |
| Device Name: | ORTHROPRO HEMI TOE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-27 |
| Decision Date | 2006-11-13 |
| Summary: | summary |