Zimmer Mis Light
FDA 510(k) K080367 · Zimmer Spine, Inc.
510(k) numberK080367
Submission
- Device name
- Zimmer Mis Light
- Applicant
- Zimmer Spine, Inc.
Minneapolis, MN, US - Received
- February 12, 2008
- Decision date
- February 22, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FST – Light, Surgical, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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|---|---|---|
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| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…KWQ · Traditional | 03/20/2015SE |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…MAX · Traditional | 02/12/2015SE |
| K142053 | Universal Clamp Spinal Fixation SystemOWI · Traditional | 10/29/2014SE |
| K141500 | Optio-C Anterior Cervical SystemKWQ · Traditional | 09/23/2014SE |
| K133556 | Virage Oct Spinal Fixation SystemKWP · Traditional | 06/02/2014SE |
| K140611 | Trinica Anterior Lumbar Plate SystemKWQ · Traditional | 05/21/2014SE |
Questions and answers
When was Zimmer Mis Light cleared by the FDA?
Zimmer Mis Light (K080367) received a 510(k) decision of Substantially Equivalent on February 22, 2008, 10 days after the submission was received.
What is the product code of K080367?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.