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
11953–11976 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 20, 2003
ORIA ZENITH
K030500 · KWQ
Ortho Tec, LLC
Orthopedic · 29d
Cleared Mar 20, 2003
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
K030501 · LPH
Biomet, Inc.
Orthopedic · 29d
Cleared Mar 20, 2003
SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES
K030597 · HRS
Synthes (Usa)
Orthopedic · 23d
Cleared Mar 20, 2003
EBI DYNAFIX COMPRESSION BONE SCREW
K030706 · HWC
Ebi, L.P.
Orthopedic · 14d
Cleared Mar 18, 2003
VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30,...
K030096 · HRX
Arthrex, Inc.
Orthopedic · 67d
Cleared Mar 17, 2003
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
K024364 · MQP
Synthes (Usa)
Orthopedic · 76d
Cleared Mar 13, 2003
MICROFIX QUICKANCHOR PLUS
K024115 · HWC
Mitek Worldwide
Orthopedic · 90d
Cleared Mar 12, 2003
OPTIMA, SPINAL SYSTEM
K024096 · MNI
U&I Corp., America
Orthopedic · 90d
Cleared Mar 11, 2003
OSSE-LIGN
K023564 · JDQ
Osseus, LLC
Orthopedic · 139d
Cleared Mar 06, 2003
KMEDIC EXTERNAL FIXATION DEVICES
K030336 · JDW
Teleflex Medical Group
Orthopedic · 34d
Cleared Mar 06, 2003
MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
K030372 · KTT
Ebi, L.P.
Orthopedic · 30d
Cleared Mar 06, 2003
ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
K030373 · LZO
Centerpulse Orthopedics, Inc.
Orthopedic · 30d
Cleared Mar 06, 2003
MODIFICATION TO SYNTHES CERVIFIX SYSTEM
K030377 · MNI
Synthes (Usa)
Orthopedic · 29d
Cleared Mar 06, 2003
REPICCI LOCKED KEEL TIBIAL BEARING
K030446 · HRY
Biomet, Inc.
Orthopedic · 23d
Cleared Mar 04, 2003
ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS
K021878 · LPH
Eska America Corp.
Orthopedic · 270d
Cleared Mar 04, 2003
NUVASIVE MASH
K023319 · MQP
Nuvasive, Inc.
Orthopedic · 151d
Cleared Mar 04, 2003
ORIA CERVICAL PLATES
K023377 · KWQ
Ortho Tec, LLC
Orthopedic · 147d
Cleared Mar 04, 2003
MIIG II BONE GRAFT SUBSTITUTE
K024336 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 67d
Cleared Mar 04, 2003
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
K030265 · JDI
Zimmer, Inc.
Orthopedic · 36d
Cleared Mar 04, 2003
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
K030344 · KWS
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Feb 26, 2003
PALABOND
K022251 · LOD
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 229d
Cleared Feb 26, 2003
STRYKER XCEL ANCHOR SYSTEM
K023013 · HWC
Stryker Endoscopy
Orthopedic · 169d
Cleared Feb 26, 2003
VERTE-SPAN SPINAL SYSTEM
K024049 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 79d
Cleared Feb 26, 2003
SMITH & NEPHEW FEMORAL HEADS
K024340 · JDI
Smith & Nephew, Inc.
Orthopedic · 61d