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
8641–8664 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 29, 2010
LATITUDE ELBOW PROSTHESIS
K100562 · JDB
Tornier, Inc.
Orthopedic · 120d
Cleared Jun 25, 2010
SYNTEC OSTEO-PLATE AND SCREW FIXATION
K092889 · HRS
Syntec Scientific Corp.
Orthopedic · 277d
Cleared Jun 25, 2010
MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM
K093104 · MNI
Medyssey Co, Ltd.
Orthopedic · 267d
Cleared Jun 25, 2010
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
K100214 · ODP
Medtronic Sofamor Danek
Orthopedic · 151d
Cleared Jun 25, 2010
REPROCESSED PINS
K100707 · NDM
Sterilmed, Inc.
Orthopedic · 105d
Cleared Jun 24, 2010
DARCO HEADED CANNULATED SCREW
K100359 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 132d
Cleared Jun 24, 2010
CONSENSUS REVISION KNEE SYSTEM
K100542 · JWH
Consensus Orthopedics, Inc.
Orthopedic · 119d
Cleared Jun 23, 2010
B-GENIN AND R-GENIN
K091912 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 363d
Cleared Jun 23, 2010
UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS
K093078 · HWC
Bonutti Research, Inc.
Orthopedic · 266d
Cleared Jun 23, 2010
NUVASIVE VUEPOINT OCT SYSTEM
K093319 · KWP
Nuvasive, Inc.
Orthopedic · 243d
Cleared Jun 23, 2010
DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820
K093707 · HSB
U&I Corp.
Orthopedic · 203d
Cleared Jun 23, 2010
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
K100409 · NKB
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 127d
Cleared Jun 23, 2010
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
K100438 · NKB
Ebi, L.P.
Orthopedic · 126d
Cleared Jun 23, 2010
ACL TIGHTROPE
K100652 · HTY
Arthrex, Inc.
Orthopedic · 107d
Cleared Jun 23, 2010
SLEEVE WITH ZIPLOOP FIXATION DEVICES
K101063 · MBI
Biomet Sports Medicine
Orthopedic · 68d
Cleared Jun 22, 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 64d
Cleared Jun 22, 2010
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
K101451 · LZO
Omni Life Science, Inc.
Orthopedic · 28d
Cleared Jun 21, 2010
QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)
K100497 · HSB
N.M.B. Medical Applications, Ltd.
Orthopedic · 119d
Cleared Jun 21, 2010
OPUS SPEEDSCREW SYSTEM
K101448 · MBI
Arthrocare Corp.
Orthopedic · 28d
Cleared Jun 18, 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100685 · KWP
Alphatec Spine, Inc.
Orthopedic · 100d
Cleared Jun 18, 2010
MOTIVATION KNEE SYSTEM
K100900 · JWH
Encore Medical, L.P.
Orthopedic · 79d
Cleared Jun 18, 2010
COMPRESS ANTI-ROTATION SPINDLES
K101475 · KWA
Biomet Manufacturing Corp
Orthopedic · 21d
Cleared Jun 17, 2010
T2 GREATER TROCHANTER NAIL
K101438 · HSB
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Jun 16, 2010
COROENT XLR STANDALONE SYSTEM
K100043 · OVD
Nuvasive, Inc.
Orthopedic · 159d