510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Amedica Corp.

Salt Lake City, UT, US

Amedica Corp. appears in FDA device records in Salt Lake City, UT. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
17
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 17 510(k) clearances for Amedica Corp. between 2002 and 2018. The busiest year on record is 2007, with 3. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Amedica Corp., by decision year
YearClearances
20021
20051
20061
20073
20083
20101
20121
20142
20151
20162
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceODPSubstantially Equivalent
K162160Preference Elite Pedicle Screw SystemNKBSubstantially Equivalent
K161405Valeo II Interbody Fusion Device SystemMAXSubstantially Equivalent
K143518Valeo Spacer System and Valeo II Interbody Fusion Device SystemMAXSubstantially Equivalent
K142264Valeo C Spacer System, Valeo II C IBF DeviceODPSubstantially Equivalent
K142347Amedica Valeo II Interbody Fusion DeviceMAXSubstantially Equivalent
K121892PHANTOM PLUS CERAMIC CAGE SYSTEMMAXSubstantially Equivalent
K091278VALEO SPACER SYSTEMMAXSubstantially Equivalent
K082037SEEPLATE CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K073430VALEO PEDICLE SCREW SPINAL SYSTEMNKBSubstantially Equivalent
K073505MODIFICATION TO VALEO VBRMQPSubstantially Equivalent
K073125VALEO VBRMQPSubstantially Equivalent
K072022VALEO PEDICLE SCREW SPINAL SYSTEMNKBSubstantially Equivalent
K071990VALEO CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K051525ARX SPINAL SYSTEMMQPSubstantially Equivalent
K050699MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004JDKSubstantially Equivalent
K022729VENTED CEMENT RESTRICTORJDXSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain