510(k) Report

FDA applicant

Amedica Corp.

Slat Lake City, UT17 decisions2002–20180 recalls

FDA records 17 decisions for Amedica Corp. (Slat Lake City, UT) from 2002 to 2018: 17 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and MQP (Spinal Vertebral Body Replacement Device). Since 2016 its 510(k)s took a median of 108 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 53 predicates, 14 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Amedica Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Amedica Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007: 32008: 32010: 12012: 12014: 22015: 12016: 22018: 1
2007high 3 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Amedica Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Amedica Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar5decisions
  • MQPSpinal Vertebral Body Replacement Device3decisions
  • NKBThoracolumbosacral Pedicle Screw System3decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions
  • JDKProsthesis, Hip, Cement Restrictor1decision

Also: JDX (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 108 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 124 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 53 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 37 times; 14 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142264Valeo C Spacer System, Valeo II C IBF DeviceAmedica Corp. · 20148cite it
  • K072022Valeo Pedicle Screw Spinal SystemAmedica Corp. · 20077cite it
  • K091278Valeo Spacer SystemAmedica Corp. · 20104cite it
  • K143518Valeo Spacer System and Valeo II Interbody Fusion Device SystemAmedica Corp. · 20153cite it
  • K121892Phantom Plus Ceramic Cage SystemAmedica Corp. · 20123cite it
  • K161405Valeo II Interbody Fusion Device SystemAmedica Corp. · 20162cite it

What has FDA decided for it lately?

  • K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp. · 2018
  • K162160Preference Elite Pedicle Screw SystemAmedica Corporation · 2016
  • K161405Valeo II Interbody Fusion Device SystemAmedica Corp. · 2016
  • K143518Valeo Spacer System and Valeo II Interbody Fusion Device SystemAmedica Corp. · 2015
  • K142264Valeo C Spacer System, Valeo II C IBF DeviceAmedica Corp. · 2014
  • K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp. · 2014
  • K121892Phantom Plus Ceramic Cage SystemAmedica Corp. · 2012
  • K091278Valeo Spacer SystemAmedica Corp. · 2010

All 16 as Amedica Corp. →The one decision as Amedica Corporation →

Other applicant names beginning “Amedica”

FDA records each applicant name separately; these may or may not be the same firm.

Amedica Biotech, Inc. 13