The following data is part of a premarket notification filed by Reiley Orthopaedics, Inc. with the FDA for Roi Fusion Rods & Plates.
| Device ID | K051309 |
| 510k Number | K051309 |
| Device Name: | ROI FUSION RODS & PLATES |
| Classification | Screw, Fixation, Bone |
| Applicant | REILEY ORTHOPAEDICS, INC. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb REILEY ORTHOPAEDICS, INC. 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 | 2005-05-19 |
| Decision Date | 2005-07-11 |
| Summary: | summary |