Quick Tap Self Drilling Screw
FDA 510(k) K982927 · Kinamed, Inc.
510(k) numberK982927
Submission
- Device name
- Quick Tap Self Drilling Screw
- Applicant
- Kinamed, Inc.
Newbury Park, CA, US - Received
- August 20, 1998
- Decision date
- September 8, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code DZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254286 | Guided Bone Regeneration SystemDZL · Traditional | DentalMaster(Xiamen)Medical Technology Co., Ltd. | 08/24/2026SE |
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)DZL · Traditional | Hager& Meisinger GmbH | 09/29/2025SE |
| K251569 | Bone ScrewDZL · Traditional | Osstem Implant Co., Ltd. | 08/13/2025SE |
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PINDZL · Traditional | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 06/27/2025SE |
| K233419 | GBR SystemDZL · Traditional | Proimtech Saglik Urunleri Anonim Sirketi | 01/03/2025SE |
| K240321 | MP Pin flat without thread (36BMP000020/MP20)DZL · Traditional | Hager& Meisinger GmbH | 10/17/2024SE |
| K233721 | KLS Martin Drill-Free MMF ScrewDZL · Traditional | KLS-Martin L.P. | 09/17/2024SE |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS ScrewsDZL · Traditional | Stryker Leibinger GmbH & Co KG | 08/24/2023SE |
| K222367 | Save GBRDZL · Traditional | Dentis Co., Ltd. | 03/23/2023SE |
| K201210 | The Micro Screw System, Micro Screw System BasicDZL · Traditional | Hager& Meisinger GmbH | 10/08/2021SE |
More from Hager& Meisinger GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K181749 | SuperCable® Iso-Elastic Cerclage SystemJDQ · Special | 08/01/2018SE |
| K122049 | Neuropro Low Profile Cranial Plating SystemGWO · Traditional | 04/05/2013SE |
| K102834 | Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter)JDQ · Special | 01/12/2011SE |
| K072250 | Supercable Grip and Plate SystemKTT · Traditional | 11/09/2007SE |
| K050897 | Navipro Shoulder Software ModuleHAW · Traditional | 05/24/2005SE |
| K033668 | Navipro Knee Software ModuleHAW · Traditional | 03/11/2004SE |
| K032950 | Gem Inset Patellar ComponentJWH · Traditional | 12/19/2003SE |
| K030256 | Iso-Elastic Cerclage SystemJDQ · Traditional | 10/21/2003SE |
| K020764 | NaviproHAW · Traditional | 06/03/2002SE |
| K013982 | Kinematch Patello-Femoral Resurfacing ImpalantKRR · Traditional | 05/21/2002SE |
Questions and answers
When was Quick Tap Self Drilling Screw cleared by the FDA?
Quick Tap Self Drilling Screw (K982927) received a 510(k) decision of Substantially Equivalent on September 8, 1998, 19 days after the submission was received.
What is the product code of K982927?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.