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
8929–8952 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 27, 2009
COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
K092150 · LOD
Biomet, Inc.
Orthopedic · 103d
Cleared Oct 27, 2009
IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT...
K092381 · HRS
Ibalance Medical, Inc.
Orthopedic · 83d
Cleared Oct 27, 2009
REVERSE SHOULDER PROSTHESIS
K092873 · PHX
Djo Surgical
Orthopedic · 39d
Cleared Oct 26, 2009
ULC SPINAL PEDICLE SCREW SYSTEM
K083077 · MNH
Otis Biotech Co., Ltd.
Orthopedic · 375d
Cleared Oct 26, 2009
TSRH SPINAL SYSTEM
K093058 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 26d
Cleared Oct 23, 2009
CURIOS
K090641 · MQV
Progentix Orthobiology BV
Orthopedic · 227d
Cleared Oct 23, 2009
COMET ANTERIOR CERVICAL PLATE SYSTEM
K090751 · KWQ
Apollo Spine, Inc.
Orthopedic · 217d
Cleared Oct 23, 2009
TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT
K090897 · LPH
Howmedica Osteonics Corp.
Orthopedic · 205d
Cleared Oct 23, 2009
VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
K091606 · NDN
Stryker Corp.
Orthopedic · 142d
Cleared Oct 23, 2009
INTERFACE ACETABULAR CUP LINERS
K092443 · LPH
Omni Life Science, Inc.
Orthopedic · 74d
Cleared Oct 20, 2009
REJUVENATE MODULAR STEM
K092561 · MEH
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Oct 19, 2009
DISTRACTABLE WAVE CAGE
K083626 · MAX
Advanced Medical Technology, Inc.
Orthopedic · 315d
Cleared Oct 19, 2009
ORTHOREX INTRA-OPERATIVE LOAD SENSOR
K090474 · ONN
Orthosensor, Inc.
Orthopedic · 237d
Cleared Oct 19, 2009
CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
K092898 · MAI
Conmed Linvatec
Orthopedic · 28d
Cleared Oct 15, 2009
C-THRU SPINAL SYSTEM
K092336 · MQP
Ebi, L.P.
Orthopedic · 72d
Cleared Oct 09, 2009
MAXMORESPINE TOM STICK
K083552 · HRX
Hoogland Spine Products, GmbH
Orthopedic · 312d
Cleared Oct 09, 2009
BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT
K090705 · JWH
Ortho Development Corp.
Orthopedic · 206d
Cleared Oct 09, 2009
LAMINOPLASTY FIXATION SYSTEM
K091623 · NQW
Nuvasive, Inc.
Orthopedic · 128d
Cleared Oct 08, 2009
HOFFMAN XPRESS LINE EXTENSION
K092834 · KTT
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Oct 06, 2009
INTERPLATE C
K092070 · KWQ
Rsb Spine, LLC
Orthopedic · 90d
Cleared Oct 06, 2009
NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
K092287 · NKB
Nuvasive, Inc.
Orthopedic · 69d
Cleared Oct 05, 2009
ADDPLUS
K090841 · MQP
Ulrich GmbH & Co. KG
Orthopedic · 192d
Cleared Oct 02, 2009
SYNERGY CANNULATED SCREW SYSTEM
K092082 · HWC
Synergy Surgical Technologies, LLC
Orthopedic · 85d
Cleared Oct 02, 2009
TSRH SPINAL SYSTEM
K092676 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 31d