The following data is part of a premarket notification filed by Orthopro Llc with the FDA for I-fuse Hammer Toe Systems.
| Device ID | K113006 |
| 510k Number | K113006 |
| Device Name: | I-FUSE HAMMER TOE SYSTEMS |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-07 |
| Decision Date | 2012-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420166173 | K113006 | 000 |
| 00840420166166 | K113006 | 000 |
| 00840420166159 | K113006 | 000 |
| 00840420166142 | K113006 | 000 |
| 00840420166135 | K113006 | 000 |
| 00840420166128 | K113006 | 000 |
| 00840420166111 | K113006 | 000 |
| 00840420166104 | K113006 | 000 |