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
9433–9456 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 08, 2008
SYNTHES RIB FIXATION SYSTEM
K081623 · HRS
Synthes (Usa)
Orthopedic · 90d
Cleared Sep 05, 2008
SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
K081016 · PHX
Smith & Nephew, Inc.
Orthopedic · 149d
Cleared Sep 05, 2008
ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR...
K081614 · ODP
Interbody Innovations, Llp
Orthopedic · 88d
Cleared Sep 04, 2008
AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
K080992 · HRS
Aesculap Implant Systems, Inc.
Orthopedic · 150d
Cleared Sep 04, 2008
BLACKSTONE PILLAR XL PEEK SPACERS
K082235 · MAX
Blackstone Medical, Inc.
Orthopedic · 28d
Cleared Sep 03, 2008
RE-ZORB PLATING SYSTEM
K081588 · HRS
Acute Innovations, LLC
Orthopedic · 90d
Cleared Sep 03, 2008
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005,...
K081758 · MQV
Depuy Spine, Inc.
Orthopedic · 75d
Cleared Sep 03, 2008
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
K082195 · NKB
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Sep 02, 2008
ANTEGRA-T
K081568 · KWQ
Synthes Spine Co.Lp
Orthopedic · 90d
Cleared Sep 02, 2008
OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++
K082022 · JWH
Exactech, Inc.
Orthopedic · 48d
Cleared Aug 29, 2008
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
K081622 · JDQ
Abbott Spine, Inc.
Orthopedic · 80d
Cleared Aug 29, 2008
EXTREMITY MEDICAL COMPRESSION SCREW
K081934 · HWC
Extremity Medical, LLC
Orthopedic · 53d
Cleared Aug 29, 2008
DEPUY C-STEM AMT
K082239 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Aug 28, 2008
SYGNAL DBM
K080405 · MBP
Musculoskeletal Transplant Foundation
Orthopedic · 196d
Cleared Aug 28, 2008
OPACITY + BONE CEMENT
K080873 · NDN
Teknimed, S.A.
Orthopedic · 150d
Cleared Aug 28, 2008
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
K081849 · OVD
Blackstone Medical, Inc.
Orthopedic · 59d
Cleared Aug 28, 2008
LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002
K082194 · HRX
Laurimed, LLC
Orthopedic · 24d
Cleared Aug 27, 2008
T2 XVBR SPINAL SYSTEM
K082112 · MQP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Aug 26, 2008
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S
K081511 · MBI
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Aug 26, 2008
SMALL BONE LOCKING PLATING SYSTEM
K081546 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Aug 25, 2008
PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC
K081558 · MQV
Pioneer Surgical Technology
Orthopedic · 83d
Cleared Aug 21, 2008
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
K081566 · LPH
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Aug 20, 2008
JMEA CANNULATED BONE SCREW SYSTEM
K080259 · HWC
Jmea Corporation
Orthopedic · 202d
Cleared Aug 20, 2008
REVELATION HIP STEM, MODELS, 427-01, 427-02
K081679 · LPH
Encore Medical, L.P.
Orthopedic · 64d