Stryker Universal Drill Attachments & Accessories
FDA 510(k) K962800 · Stryker Instruments
510(k) numberK962800
Submission
- Device name
- Stryker Universal Drill Attachments & Accessories
- Applicant
- Stryker Instruments
Kalamazoo, MI, US - Received
- July 18, 1996
- Decision date
- September 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K143191 | IntelliSense DrillHWE · Traditional | Mcginley Innovations | 02/20/2015SE |
| K102743 | Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresHWE · Traditional | Ortho Solutions Limited | 01/20/2011SE |
| K063688 | Surgical Irrigation System, Irrigation TubeHWE · Special | The Anspach Effort, Inc. | 01/16/2007SE |
| K050766 | Explant Osteonecrosis Intervention Implant Removal SystemHWE · Traditional | Zimmer Trabecular | 05/26/2005SE |
| K043310 | Synthes (USA) Electric Pen Drive SystemHWE · Traditional | Synthes (Usa) | 01/05/2005SE |
| K022744 | Reprocessed Used Disposable Arthroscopic Blades and BursHWE · Traditional | Medical Device Services | 09/18/2002SE |
| K012694 | Reprocessed Used Disposable Arthroscopic Blades and BursHWE · Traditional | Adven Medical | 02/04/2002SE |
| K012676 | Reprocessed Used, Disposable Blades, Burs, Bits and TapsHWE · Traditional | Adven Medical | 02/04/2002SE |
| K990816 | Avcore SystemHWE · Traditional | Modular Cutting Systems, Inc. | 09/24/1999SE |
| K973736 | Aesculap Hilan Motor SystemHWE · Traditional | Aesculap, Inc. | 12/29/1997SE |
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Questions and answers
When was Stryker Universal Drill Attachments & Accessories cleared by the FDA?
Stryker Universal Drill Attachments & Accessories (K962800) received a 510(k) decision of Substantially Equivalent on September 11, 1996, 55 days after the submission was received.
What is the product code of K962800?
The FDA product code is HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.