The following data is part of a premarket notification filed by Osteotomy Guide Co. with the FDA for Reese Arthrodesis Screw.
| Device ID | K860323 |
| 510k Number | K860323 |
| Device Name: | REESE ARTHRODESIS SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | OSTEOTOMY GUIDE CO. 1450 S. DOBSON RD. STE 201 Mesa, AZ 85202 |
| Contact | William Reese |
| Correspondent | William Reese OSTEOTOMY GUIDE CO. 1450 S. DOBSON RD. STE 201 Mesa, AZ 85202 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-29 |
| Decision Date | 1986-02-19 |