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
9457–9480 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 18, 2008
REPROCESSED EXTERNAL FIXATION DEVICE
K081586 · KTT
Sterilmed, Inc.
Orthopedic · 74d
Cleared Aug 15, 2008
HIPLOC COMPRESSION HIP SCREW
K080685 · JDO
Biomet Manufacturing, Inc.
Orthopedic · 157d
Cleared Aug 15, 2008
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K081038 · KWQ
Medtronic Sofamor Danek
Orthopedic · 126d
Cleared Aug 13, 2008
TRAUSON BONE PLATE
K073432 · HRS
Trauson (Jiangsu) Medical Instrument...
Orthopedic · 251d
Cleared Aug 13, 2008
REPROCESSED EXTERNAL FIXATION ACCESSORIES
K081342 · KTT
Sterilmed, Inc.
Orthopedic · 92d
Cleared Aug 12, 2008
BIOACTIF OSTEOTRANS INTERFENCE SCREW
K081390 · HWC
Takiron Co., Ltd.
Orthopedic · 85d
Cleared Aug 11, 2008
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION
K082148 · HSB
Synthes (Usa)
Orthopedic · 12d
Cleared Aug 08, 2008
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
K080990 · HSD
DePuy Orthopaedics, Inc.
Orthopedic · 123d
Cleared Aug 07, 2008
VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES
K073499 · JDL
Zimmer, Inc.
Orthopedic · 238d
Cleared Aug 07, 2008
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE
K081051 · HRX
Spine View, Inc.
Orthopedic · 115d
Cleared Aug 07, 2008
PEEK-OPTIMA ALIF SPACER
K081636 · MAX
Biomet Spine
Orthopedic · 57d
Cleared Aug 07, 2008
METHA SHORT STEM HIP SYSTEM
K081973 · LZO
Aesculap Implant Systems, Inc.
Orthopedic · 28d
Cleared Aug 06, 2008
DIGIMATCH ROBODOC SURGICAL SYSTEM
K072629 · OJP
Integrated Surgical Systems, Inc.
Orthopedic · 324d
Cleared Aug 05, 2008
BIOPRO GO-EZ SCREW
K081149 · HWC
Biopro, Inc.
Orthopedic · 105d
Cleared Aug 05, 2008
MODIFICATION TO LUCENT
K081968 · MAX
Spinal Elements, Inc.
Orthopedic · 26d
Cleared Aug 04, 2008
TIGER CANNULATED SCREW SYSTEM
K081510 · HWC
Trilliant Surgical, Ltd.
Orthopedic · 67d
Cleared Aug 01, 2008
OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING
K081876 · KWD
Osteomed LP
Orthopedic · 30d
Cleared Jul 31, 2008
MDF REVISION HIP SYSTEM
K081124 · MEH
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Jul 30, 2008
LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS
K081244 · KTT
Biomet Trauma
Orthopedic · 90d
Cleared Jul 29, 2008
MAESTRO WRIST FRACTURE IMPLANT
K080426 · JWJ
Biomet Manufacturing Corp
Orthopedic · 160d
Cleared Jul 28, 2008
OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS...
K081497 · MBI
Arthrocare Corp.
Orthopedic · 60d
Cleared Jul 28, 2008
STRYKER SPINE AVS PL PEEK SPACERS
K082014 · MAX
Stryker Corp.
Orthopedic · 13d
Cleared Jul 25, 2008
RELIEVE LAMINOPLASTY FIXATION SYSTEM
K080664 · NQW
Globus Medical, Inc.
Orthopedic · 137d
Cleared Jul 24, 2008
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
K081351 · HSX
Smith & Nephew, Inc.
Orthopedic · 71d