The following data is part of a premarket notification filed by Scientific Spinal Ltd. with the FDA for Edwards Anato Hook/univ Rod/wash/sacr Screw/adj Co.
| Device ID | K914269 |
| 510k Number | K914269 |
| Device Name: | EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SCIENTIFIC SPINAL LTD. SCHOOL OF MEDICINE DEPTMENT OF SURGERY Baltimore, MD 21201 |
| Contact | Charles C Edwards |
| Correspondent | Charles C Edwards SCIENTIFIC SPINAL LTD. SCHOOL OF MEDICINE DEPTMENT OF SURGERY Baltimore, MD 21201 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-24 |
| Decision Date | 1991-12-18 |