The following data is part of a premarket notification filed by R-x-fix with the FDA for R-x-fix External Fixator.
| Device ID | K051017 |
| 510k Number | K051017 |
| Device Name: | R-X-FIX EXTERNAL FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | R-X-FIX 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb R-X-FIX 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-21 |
| Decision Date | 2005-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420197566 | K051017 | 000 |
| 00840420197559 | K051017 | 000 |
| 00840420197528 | K051017 | 000 |
| 00840420197511 | K051017 | 000 |
| 00840420197504 | K051017 | 000 |
| 00840420197481 | K051017 | 000 |
| 00840420197474 | K051017 | 000 |
| 00840420170613 | K051017 | 000 |