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
12025–12048 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 15, 2003
MODIFICATION TO EBI XFIX DFS SYSTEM
K024129 · KTT
Ebi, L.P.
Orthopedic · 30d
Cleared Jan 15, 2003
UNI HIP STEM
K024134 · LWJ
Plus Orthopedics
Orthopedic · 30d
Cleared Jan 15, 2003
NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS
K024161 · JWH
Implex Corp.
Orthopedic · 29d
Cleared Jan 09, 2003
CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P
K022622 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 155d
Cleared Jan 09, 2003
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
K024086 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 29d
Cleared Dec 30, 2002
NARROW ASCENT INTERLOK FEMORAL COMPONENTS
K024037 · JWH
Biomet, Inc.
Orthopedic · 24d
Cleared Dec 27, 2002
MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM
K023388 · JDR
Mitek Worldwide
Orthopedic · 79d
Cleared Dec 24, 2002
TELEGRAPH HUMERAL NAIL
K023241 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 85d
Cleared Dec 24, 2002
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
K023667 · KRO
Plus Orthopedics
Orthopedic · 54d
Cleared Dec 20, 2002
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES
K021826 · KWZ
Zimmer, Inc.
Orthopedic · 199d
Cleared Dec 20, 2002
MITEK PDS/PGA STAPLE
K021953 · JDR
Mitek Worldwide
Orthopedic · 190d
Cleared Dec 20, 2002
COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
K023922 · HWC
Coapt Systems, Inc.
Orthopedic · 25d
Cleared Dec 20, 2002
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060 · HWC
Howmedica Osteonics Corp.
Orthopedic · 11d
Cleared Dec 19, 2002
REFLECTION CONSTRAINED LINER
K021803 · KWZ
Smith & Nephew, Inc.
Orthopedic · 199d
Cleared Dec 19, 2002
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862 · MQV
Synthes (Usa)
Orthopedic · 29d
Cleared Dec 18, 2002
ACE VERSANAIL
K023115 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Dec 18, 2002
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
K023119 · HTN
Arthrex, Inc.
Orthopedic · 90d
Cleared Dec 16, 2002
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
K023087 · KRO
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 13, 2002
COMPREHENSIVE HUMERAL FRACTURE SYSTEM
K023063 · KWT
Biomet Orthopedics, Inc.
Orthopedic · 88d
Cleared Dec 13, 2002
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
K023415 · KWP
Medtronic Sofamor Danek
Orthopedic · 63d
Cleared Dec 13, 2002
COLUMBUS (CR) TOTAL KNEE SYSTEM
K023788 · JWH
Aesculap, Inc.
Orthopedic · 30d
Cleared Dec 13, 2002
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
K023797 · KWP
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Dec 12, 2002
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
K023770 · KWD
Kinetikos Medical, Inc.
Orthopedic · 30d
Cleared Dec 11, 2002
BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
K021039 · KWQ
Depuyacromed
Orthopedic · 254d