The following data is part of a premarket notification filed by Surgicraft Ltd. with the FDA for Titanium Hartshill System.
| Device ID | K991662 |
| 510k Number | K991662 |
| Device Name: | TITANIUM HARTSHILL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SURGICRAFT LTD. FISHING LINE RD. Redditch, Worcs., GB B97 6hf |
| Contact | Simon Fitzer |
| Correspondent | Simon Fitzer SURGICRAFT LTD. FISHING LINE RD. Redditch, Worcs., GB B97 6hf |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-14 |
| Decision Date | 1999-11-08 |
| Summary: | summary |