The following data is part of a premarket notification filed by Ace Orthopedic Manufacturing Co. with the FDA for Ace/kyle Captured Hip Screw.
| Device ID | K813554 |
| 510k Number | K813554 |
| Device Name: | ACE/KYLE CAPTURED HIP SCREW |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ACE ORTHOPEDIC MANUFACTURING CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-22 |
| Decision Date | 1982-01-12 |