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
12097–12120 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 06, 2002
ARCPM 1050 RESIN-HIPS
K023357 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Nov 05, 2002
WMT-TCP BONE GRAFT SUBSTITUTE
K022629 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Nov 01, 2002
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K021551 · MQV
Biocomposites, Ltd.
Orthopedic · 172d
Cleared Nov 01, 2002
K-FIX
K022597 · HTY
New Deal, S.A.
Orthopedic · 88d
Cleared Oct 31, 2002
OSSTAPLE, MAXILLOFACIAL
K023486 · JEY
Biomedical Enterprises, Inc.
Orthopedic · 14d
Cleared Oct 31, 2002
OSSTAPLE, CRANIOFACIAL
K023488 · JEY
Biomedical Enterprises, Inc.
Orthopedic · 14d
Cleared Oct 30, 2002
NEWDEAL K WIRE
K022599 · HTY
New Deal, S.A.
Orthopedic · 86d
Cleared Oct 29, 2002
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
K022615 · JDK
Centerpulse Spine-Tech, Inc.
Orthopedic · 83d
Cleared Oct 25, 2002
INCOMPASS SPINAL FIXATION SYSTEM
K021564 · KWQ
Spinal Concepts, Inc.
Orthopedic · 165d
Cleared Oct 25, 2002
RINGLOC CONSTRAINED LINERS
K021661 · KWZ
Biomet Orthopedics, Inc.
Orthopedic · 158d
Cleared Oct 25, 2002
RINGLOC CONSTRAINED LINERS II
K021728 · KWZ
Biomet, Inc.
Orthopedic · 154d
Cleared Oct 25, 2002
ECHELON POROUS PLUS HA HIP STEMS
K023302 · MEH
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Oct 25, 2002
LEFORTE SYSTEM BONE PLATE
K023360 · KTW
Jeil Medical Corporation
Orthopedic · 18d
Cleared Oct 25, 2002
MODIFICATION TO ESOP CO-CR FEMORAL HEADS
K023375 · LPH
Pro-Active Healthcare
Orthopedic · 17d
Cleared Oct 25, 2002
EBI XFIX DFS SYSTEM
K023399 · KTT
Ebi, L.P.
Orthopedic · 16d
Cleared Oct 18, 2002
DURACON CS TIBIAL INSERT
K021451 · JWH
Howmedica Osteonics Corp.
Orthopedic · 165d
Cleared Oct 18, 2002
VKS KNEE SYSTEM
K022204 · JWH
Plus Orthopedics
Orthopedic · 105d
Cleared Oct 18, 2002
MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K023133 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Oct 18, 2002
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
K023204 · MNH
Ebi, L.P.
Orthopedic · 23d
Cleared Oct 18, 2002
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
K023260 · HWC
Osteomed Corp.
Orthopedic · 18d
Cleared Oct 18, 2002
MICROFIX
K023314 · KTT
Fixano SA
Orthopedic · 45d
Cleared Oct 18, 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K023324 · KTT
Ebi, L.P.
Orthopedic · 14d
Cleared Oct 17, 2002
BIOSTEON CROSS PIN
K021351 · HWC
Biocomposites, Ltd.
Orthopedic · 171d
Cleared Oct 17, 2002
GMRS PRESS FIT STEMS WITH PUREFIX HA
K022403 · LZO
Howmedica Osteonics Corp.
Orthopedic · 86d