The following data is part of a premarket notification filed by S & S Orthopedic Ltd. with the FDA for S & S Orthopedic Wire Driver 701.
| Device ID | K944488 |
| 510k Number | K944488 |
| Device Name: | S & S ORTHOPEDIC WIRE DRIVER 701 |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | S & S ORTHOPEDIC LTD. 701 WESTMONT DR. Asheboro, NC 27203 |
| Contact | Frank Sefcik |
| Correspondent | Frank Sefcik S & S ORTHOPEDIC LTD. 701 WESTMONT DR. Asheboro, NC 27203 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-13 |
| Decision Date | 1995-03-02 |