The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Quick Tap Self Drilling Screw.
| Device ID | K982927 |
| 510k Number | K982927 |
| Device Name: | QUICK TAP SELF DRILLING SCREW |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
| Contact | Robert Bruce |
| Correspondent | Robert Bruce KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-20 |
| Decision Date | 1998-09-08 |