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
6961–6984 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 08, 2013
OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM
K131810 · MNH
Osseus Fusion Systems, LLC
Orthopedic · 50d
Cleared Aug 07, 2013
FIREBIRD SPINAL FIXATION SYSTEM
K130932 · NKB
Orthofix, Inc.
Orthopedic · 125d
Cleared Aug 07, 2013
INTEGRA TITANIUM BONE WEDGE
K131360 · HRS
Ascension Orthopedic
Orthopedic · 86d
Cleared Aug 07, 2013
KATIA SYSTEM
K131512 · KWQ
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 71d
Cleared Aug 07, 2013
I.T.S. EXTREMITY FIXATION SYSTEMS
K131722 · HRS
I.T.S. GmbH
Orthopedic · 56d
Cleared Aug 06, 2013
SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
K130126 · MBF
Biomet, Inc.
Orthopedic · 201d
Cleared Aug 06, 2013
CD HORIZON SPINAL SYSTEM
K132111 · NKB
Medtronic Sofamor Danek USA
Orthopedic · 28d
Cleared Aug 05, 2013
EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE...
K122883 · JWH
Stelkast Company
Orthopedic · 319d
Cleared Aug 04, 2013
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
K130748 · OLO
Smith & Nephew, Inc.
Orthopedic · 138d
Cleared Aug 02, 2013
NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
K123347 · HRS
Normed Medizin-Technik GmbH
Orthopedic · 275d
Cleared Aug 01, 2013
TOGGLELOC XTENDER
K130033 · MBI
Biomet Manufacturing Corp
Orthopedic · 209d
Cleared Aug 01, 2013
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM,...
K130814 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 129d
Cleared Jul 30, 2013
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM,...
K130302 · MNI
Spinevision S.A.
Orthopedic · 173d
Cleared Jul 30, 2013
COALITION SPACER
K131449 · OVE
Globus Medical, Inc.
Orthopedic · 71d
Cleared Jul 29, 2013
MULTIFIX S KNOTLESS FIXATION DEVICE
K131182 · MBI
Arthocare Corporation
Orthopedic · 94d
Cleared Jul 26, 2013
GMK REVISION EXTENSION
K123721 · JWH
Medacta International
Orthopedic · 234d
Cleared Jul 26, 2013
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
K130478 · MAX
Globus Medical, Inc.
Orthopedic · 151d
Cleared Jul 26, 2013
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
K131264 · HWC
Gebr. Brasseler GmbH & Co. KG
Orthopedic · 84d
Cleared Jul 25, 2013
CAPSTONE(R) SPINAL SYSTEM
K123027 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 300d
Cleared Jul 25, 2013
COMPRESSYN BAND
K130431 · JDQ
Dallen Medical, Inc.
Orthopedic · 154d
Cleared Jul 25, 2013
HAMMERTOE CORRECTION SYSTEM
K130859 · HWC
Arthrosurface, Inc.
Orthopedic · 119d
Cleared Jul 25, 2013
JONES-FX FRACTURE SYSTEM
K131620 · HWC
Instratek, Inc.
Orthopedic · 52d
Cleared Jul 25, 2013
HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)
K131974 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 27d
Cleared Jul 24, 2013
REFORM PEDICLE SCREW SYSTEM
K131343 · MNI
Spinal USA
Orthopedic · 76d