The following data is part of a premarket notification filed by Osteotomy Guide Co. with the FDA for Shortening Osteotomy Guide.
| Device ID | K861576 |
| 510k Number | K861576 |
| Device Name: | SHORTENING OSTEOTOMY GUIDE |
| Classification | Protractor |
| 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 | HTH |
| CFR Regulation Number | 888.4600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-28 |
| Decision Date | 1986-05-12 |