The following data is part of a premarket notification filed by Ortho-pro Llc with the FDA for Orthoflex Rod.
| Device ID | K102601 |
| 510k Number | K102601 |
| Device Name: | ORTHOFLEX ROD |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | ORTHO-PRO LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb ORTHO-PRO LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-09 |
| Decision Date | 2011-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420170378 | K102601 | 000 |
| 00840420170361 | K102601 | 000 |
| 00840420170354 | K102601 | 000 |
| 00840420170347 | K102601 | 000 |