The following data is part of a premarket notification filed by Surgicraft Ltd. with the FDA for Ransford Cervical Fixation System.
| Device ID | K965221 |
| 510k Number | K965221 |
| Device Name: | RANSFORD CERVICAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SURGICRAFT LTD. 16 THE OAKS, CLEWS ROAD Redditch, Worcestershire, GB B98 7st |
| Contact | Peter Dines |
| Correspondent | Peter Dines SURGICRAFT LTD. 16 THE OAKS, CLEWS ROAD Redditch, Worcestershire, GB B98 7st |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-31 |
| Decision Date | 1997-08-07 |
| Summary: | summary |