The following data is part of a premarket notification filed by R&r Medical, Inc. with the FDA for R&r External Fixation System.
| Device ID | K052005 |
| 510k Number | K052005 |
| Device Name: | R&R EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | R&R MEDICAL, INC. 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb R&R MEDICAL, INC. 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 | 2005-07-25 |
| Decision Date | 2005-09-06 |
| Summary: | summary |