Spartan S3 Facet System
FDA 510(k) K113011 · Amendia, Inc.
510(k) numberK113011
Submission
- Device name
- Spartan S3 Facet System
- Applicant
- Amendia, Inc.
Apple Valley, MN, US - Received
- October 11, 2011
- Decision date
- December 6, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRW – System, Facet Screw Spinal Device
- Device class
- Unclassified
- Implant
- Yes
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| K250920 | Arthrex Spine Compression FT ScrewMRW · Traditional | Arthrex, Inc. | 05/22/2025SE |
| K242527 | The Karma® Fixation SystemMRW · Traditional | Spinal Elements, Inc. | 05/21/2025SE |
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| K160291 | Optimus ALIF SystemOVD · Special | 02/18/2016SE |
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| K151310 | Amendia Interbody Fusion DevicesMAX · Traditional | 01/06/2016SE |
| K152460 | Rectangular Corpectomy CageMQP · Traditional | 12/22/2015SE |
| K152455 | Amendia Cervical Plate SystemKWQ · Traditional | 10/15/2015SE |
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Questions and answers
When was Spartan S3 Facet System cleared by the FDA?
Spartan S3 Facet System (K113011) received a 510(k) decision of Substantially Equivalent on December 6, 2011, 56 days after the submission was received.
What is the product code of K113011?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.