Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Amedica Corp. — Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

91 daysmedian FDA review time
272 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp.2018-03-051190
K161405Valeo II Interbody Fusion Device SystemAmedica Corp.2016-08-19910
K143518Valeo Spacer System and Valeo II Interbody Fusion Device SysAmedica Corp.2015-10-022940
K142264Valeo C Spacer System, Valeo II C IBF DeviceAmedica Corp.2014-12-081150
K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.2014-11-18880
K121892PHANTOM PLUS CERAMIC CAGE SYSTEMAmedica Corp.2012-08-24560
K091278VALEO SPACER SYSTEMAmedica Corp.2010-01-282720
K082037SEEPLATE CERVICAL PLATE SYSTEMAmedica Corp.2008-09-26710
K073430VALEO PEDICLE SCREW SPINAL SYSTEMAmedica Corp.2008-01-29540
K073505MODIFICATION TO VALEO VBRAmedica Corp.2008-01-09270
K073125VALEO VBRAmedica Corp.2007-12-05290
K072022VALEO PEDICLE SCREW SPINAL SYSTEMAmedica Corp.2007-11-191190
K071990VALEO CERVICAL PLATE SYSTEMAmedica Corp.2007-10-291010
K051525ARX SPINAL SYSTEMAmedica Corp.2006-02-172540
K050699MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-0Amedica Corp.2005-04-15280
K022729VENTED CEMENT RESTRICTORAmedica Corp.2002-11-14900

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda