The following data is part of a premarket notification filed by A.w. Showell (surgicraft) Ltd. with the FDA for Hartshill Rect & Wires, Spinal Fixation System.
| Device ID | K853033 |
| 510k Number | K853033 |
| Device Name: | HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | A.W. SHOWELL (SURGICRAFT) LTD. BRITTEN ST. REDDITCH Worcs. B97 6hf England, GB |
| Contact | A. D Showell |
| Correspondent | A. D Showell A.W. SHOWELL (SURGICRAFT) LTD. BRITTEN ST. REDDITCH Worcs. B97 6hf England, GB |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-18 |
| Decision Date | 1985-09-24 |