Valeo Spacer System
FDA 510(k) K091278 · Amedica Corp.
510(k) numberK091278
Submission
- Device name
- Valeo Spacer System
- Applicant
- Amedica Corp.
Salt Lake City, UT, US - Received
- May 1, 2009
- Decision date
- January 28, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
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| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
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| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173453 | Valeo® C+CSC with Lumen Interbody Fusion DeviceODP · Traditional | 03/05/2018SE |
| K162160 | Preference Elite Pedicle Screw SystemNKB · Traditional | 11/18/2016SE |
| K161405 | Valeo II Interbody Fusion Device SystemMAX · Special | 08/19/2016SE |
| K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device SystemMAX · Traditional | 10/02/2015SE |
| K142264 | Valeo C Spacer System, Valeo II C IBF DeviceODP · Traditional | 12/08/2014SE |
| K142347 | Amedica Valeo II Interbody Fusion DeviceMAX · Traditional | 11/18/2014SE |
| K121892 | Phantom Plus Ceramic Cage SystemMAX · Special | 08/24/2012SE |
| K082037 | Seeplate Cervical Plate SystemKWQ · Special | 09/26/2008SE |
| K073430 | Valeo Pedicle Screw Spinal SystemNKB · Traditional | 01/29/2008SE |
| K073505 | Modification to Valeo VBRMQP · Special | 01/09/2008SE |
Questions and answers
When was Valeo Spacer System cleared by the FDA?
Valeo Spacer System (K091278) received a 510(k) decision of Substantially Equivalent on January 28, 2010, 272 days after the submission was received.
What is the product code of K091278?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.