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
8761–8784 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 19, 2010
SMPLE PLATE AND SCREWS
K093983 · HRS
Biomet Trauma (Aka Ebi, Lp)
Orthopedic · 85d
Cleared Mar 19, 2010
OPUS SPEEDSCREW SYSTEM
K100457 · HWC
Arthrocare Corp.
Orthopedic · 30d
Cleared Mar 18, 2010
IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500,...
K093419 · NDN
Stryker Instruments, Instruments Div.
Orthopedic · 136d
Cleared Mar 18, 2010
SEC IBF CAGE
K093669 · MAX
Innvotec Surgical, Inc.
Orthopedic · 111d
Cleared Mar 18, 2010
MODIFICATION TO: OASYS SYSTEM
K093670 · MNH
Stryker Spine
Orthopedic · 111d
Cleared Mar 18, 2010
ARTHREX TIBIAL GRAFTBOLT
K093912 · MBI
Arthrex, Inc.
Orthopedic · 86d
Cleared Mar 17, 2010
OMNITECH LARGE, TRIMED COMPRESSION SCREW
K093676 · HWC
TriMed, Inc.
Orthopedic · 110d
Cleared Mar 17, 2010
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819
K100532 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 20d
Cleared Mar 16, 2010
APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER
K092825 · KWP
Spinecraft, Inc.
Orthopedic · 186d
Cleared Mar 16, 2010
IMPIX MANTA CERVICAL INTERBODY DEVICE
K100484 · ODP
Medicrea
Orthopedic · 26d
Cleared Mar 12, 2010
VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS
K092265 · MEH
Medacta International S.A.
Orthopedic · 226d
Cleared Mar 11, 2010
PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS
K092474 · KWQ
K2m, Inc.
Orthopedic · 211d
Cleared Mar 11, 2010
AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX
K093864 · MAX
Stryker Corp.
Orthopedic · 84d
Cleared Mar 11, 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093936 · MNI
Spineart
Orthopedic · 79d
Cleared Mar 10, 2010
TC PLATING SYSTEM
K094037 · HRS
Ortho-Pro, LLC
Orthopedic · 70d
Cleared Mar 09, 2010
SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM
K093629 · OVD
Biomet Spine
Orthopedic · 106d
Cleared Mar 09, 2010
SYNTHES MATRIX MIS RODS
K093668 · NKB
Synthes (Usa)
Orthopedic · 102d
Cleared Mar 09, 2010
E1 ANTIOXIDANT INFUSED TECHNOLOGY
K100048 · OIY
Biomet Manufacturing Corp
Orthopedic · 60d
Cleared Mar 05, 2010
CHESAPEAKE SPINAL SYSTEM
K092211 · OVD
K2m, Inc.
Orthopedic · 226d
Cleared Mar 05, 2010
STRYKER ARTHROSCOPE
K093677 · HRX
Stryker Endoscopy
Orthopedic · 98d
Cleared Mar 05, 2010
OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM
K093761 · HRS
Biomet Trauma (Aka Ebi, Lp)
Orthopedic · 88d
Cleared Mar 05, 2010
BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM
K093943 · MBI
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 73d
Cleared Mar 05, 2010
TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
K094017 · JWH
Omni Life Science, Inc.
Orthopedic · 66d
Cleared Mar 04, 2010
AESCULAP HYDROLIFT VBR SYSTEM
K083186 · MQP
Aesculap Implant System, Inc.
Orthopedic · 491d