Taps for Resorbable Screws
FDA 510(k) K153587 · Synthes (USA) Products, LLC
510(k) numberK153587
Submission
- Device name
- Taps for Resorbable Screws
- Applicant
- Synthes (USA) Products, LLC
West Chester, PA, US - Received
- December 16, 2015
- Decision date
- January 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K022712 | Hand Drill, Model 11-9901-7HBG · Traditional | Medical Design, LLC | 11/12/2002SE |
| K022370 | Framelock; Framelock AccessoriesHBG · Traditional | Medtronic Xomed, Inc. | 10/18/2002SE |
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| K915546 | PS Medical Ventriculostomy KitHBG · Traditional | Pudenz-Schulte Medical Research Corp. | 12/30/1991SE |
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Questions and answers
When was Taps for Resorbable Screws cleared by the FDA?
Taps for Resorbable Screws (K153587) received a 510(k) decision of Substantially Equivalent on January 18, 2017, 399 days after the submission was received.
What is the product code of K153587?
The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.