FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
6313–6336 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 18, 2014
CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM
K140585 · OJP
Curexo Technology Corporation
Orthopedic · 164d
Cleared Aug 18, 2014
M.U.S.T. EXTENSION
K141044 · NKB
Medacta International
Orthopedic · 117d
Cleared Aug 18, 2014
BIOLOX DELTA CERAMIC OPTION HEADS
K141653 · LZO
Biomet, Inc.
Orthopedic · 59d
Cleared Aug 15, 2014
THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS
K132049 · NKB
Choicespine
Orthopedic · 409d
Cleared Aug 15, 2014
EXACTECH CERVICAL SPACER SYSTEM
K141129 · ODP
Exactech, Inc.
Orthopedic · 106d
Cleared Aug 15, 2014
ARTHREX ANKLE FUSION PLATING SYSTEM
K141735 · HRS
Arthrex, Inc.
Orthopedic · 49d
Cleared Aug 14, 2014
ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
K140508 · HRS
Zimmer, Inc.
Orthopedic · 167d
Cleared Aug 14, 2014
KIVA VCF TREATMENT SYSTEM
K141141 · NDN
Benvenue Medical, Inc.
Orthopedic · 104d
Cleared Aug 13, 2014
ARTHREX FIBERTAK SUTURE ANCHOR
K140476 · MBI
Arthrex, Inc.
Orthopedic · 168d
Cleared Aug 13, 2014
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
K141517 · HRS
Zimmer, Inc.
Orthopedic · 65d
Cleared Aug 13, 2014
ZIMMER PERIARTICULAR LOCKING SYSTEM
K141734 · HRS
Zimmer, Inc.
Orthopedic · 47d
Cleared Aug 13, 2014
FIBERGRAFT BG MORSELS
K141956 · MQV
Prosidyan, Inc.
Orthopedic · 26d
Cleared Aug 07, 2014
LATERAL VBR SYSTEM
K140563 · MQP
Nu Vasive, Incorporated
Orthopedic · 155d
Cleared Aug 07, 2014
Z-LINK CERVICAL
K141005 · OVE
Zavation, LLC
Orthopedic · 111d
Cleared Aug 07, 2014
MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM
K141241 · HRS
Synthes USA Products, LLC
Orthopedic · 86d
Cleared Aug 07, 2014
AAP LOQTEC CLAVICLE PLATES 2.7/3.5
K141823 · HRS
Aap Implantate AG
Orthopedic · 31d
Cleared Aug 07, 2014
VARIAX 2 SYSTEM
K141992 · HRS
Stryker Trauma AG
Orthopedic · 16d
Cleared Aug 06, 2014
AEQUALIS REVERSED SHOULDER PROSTHESIS
K140478 · PHX
Tornier S.A.S.
Orthopedic · 161d
Cleared Aug 06, 2014
MINIMA S SYSTEM
K141327 · LZO
Lima Corporate S.P.A.
Orthopedic · 77d
Cleared Aug 06, 2014
CD HORIZON SPINAL SYSTEM
K141494 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 61d
Cleared Aug 05, 2014
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
K141056 · MBH
Stryker Orthopaedics
Orthopedic · 103d
Cleared Aug 04, 2014
SKAFFOLD NMX BONE VOID FILLER
K132211 · MQV
Skeletal Kinetics, LLC
Orthopedic · 384d
Cleared Aug 04, 2014
AS20 COMPOSITE GRAFT
K141746 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared Aug 01, 2014
INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP
K141841 · MQV
Integra Lifescience Corportation
Orthopedic · 24d