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
10609–10632 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 09, 2006
CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM
K053488 · NPJ
Conformis, Inc.
Orthopedic · 84d
Cleared Mar 08, 2006
COLLOSS E BONE VOID FILLER
K051047 · MQV
Ossacur AG
Orthopedic · 317d
Cleared Mar 08, 2006
GSS PEDICLE SCREW SYSTEM
K053573 · MNH
GS Medical Co., Ltd.
Orthopedic · 76d
Cleared Mar 07, 2006
CSS CANNULATED SCREW SYSTEM
K060428 · HWC
Orthohelix Surgical Designs, Inc.
Orthopedic · 14d
Cleared Mar 06, 2006
NOVABONE PUTTY - RESORBABLE BONE VOID FILLER
K051617 · MQV
Novabone Products, LLC
Orthopedic · 262d
Cleared Mar 06, 2006
ALLOMATRIX CUSTOM
K053319 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 96d
Cleared Mar 06, 2006
ATHROCARE TOPAZ ARTHROWANDS
K053567 · HRX
Arthrocare Corp.
Orthopedic · 74d
Cleared Mar 06, 2006
ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
K060009 · JDQ
Abbott Spine, Inc.
Orthopedic · 62d
Cleared Mar 06, 2006
XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM
K060361 · NKB
Stryker Spine
Orthopedic · 21d
Cleared Mar 06, 2006
EBI ANTERIOR CERVICAL PLATE SYSTEM
K060379 · KWQ
Ebi, L.P.
Orthopedic · 20d
Cleared Mar 02, 2006
AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
K060209 · KWS
Tornier
Orthopedic · 34d
Cleared Mar 01, 2006
U2 TOTAL KNEE SYSTEM
K051640 · JWH
United Orthopedic Corp.
Orthopedic · 254d
Cleared Mar 01, 2006
STRYKER INJECTABLE CEMENT
K060061 · MQV
Stryker Corp.
Orthopedic · 51d
Cleared Feb 27, 2006
DRLOCK DISTAL RADIUS VOLAR SYSTEM
K053182 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 105d
Cleared Feb 27, 2006
TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS
K053340 · MBH
Zimmer Trabecular
Orthopedic · 88d
Cleared Feb 27, 2006
MIIG SR
K060011 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 55d
Cleared Feb 27, 2006
SHOULDER FIXATION SYSTEM
K060290 · LXT
Hand Innovations, LLC
Orthopedic · 21d
Cleared Feb 24, 2006
DISC-FX SYSTEM
K052241 · HRX
Ellman International, Inc.
Orthopedic · 191d
Cleared Feb 24, 2006
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
K060350 · MQP
Blackstone Medical, Inc.
Orthopedic · 14d
Cleared Feb 23, 2006
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE...
K053344 · HWC
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Feb 23, 2006
BIO-MINI REVO SUTURE ANCHOR
K053561 · HWC
Conmed Linvatec
Orthopedic · 64d
Cleared Feb 23, 2006
MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
K060017 · HSX
Mako Surgical Corp.
Orthopedic · 50d
Cleared Feb 23, 2006
STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.
K060253 · HWC
Regeneration Technologies, Inc.
Orthopedic · 22d
Cleared Feb 22, 2006
TRANSET SYSTEM
K060283 · HTY
Bonutti Research, Inc.
Orthopedic · 19d