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
5929–5952 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 02, 2015
Reliance Interspinous Plate System
K142217 · PEK
Reliance Medical Systems, LLC
Orthopedic · 233d
Cleared Apr 02, 2015
PHYSICA KR KNEE SYSTEM
K141934 · JWH
Lima Corporate S.P.A.
Orthopedic · 259d
Cleared Mar 31, 2015
Range/Denali/Mesa Spinal System
K150325 · NKB
K2m, Inc.
Orthopedic · 50d
Cleared Mar 31, 2015
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert...
K143165 · HWC
Zimmer, Inc.
Orthopedic · 148d
Cleared Mar 31, 2015
Coalition AGX Plate and Coalition AGX Spacer
K142218 · ODP
Globus Medical, Inc.
Orthopedic · 231d
Cleared Mar 30, 2015
Biomet Proximal Humerus Plating System
K143697 · HRS
Biomet Manufacturing
Orthopedic · 96d
Cleared Mar 30, 2015
Eminent Foot Plate System
K143365 · HRS
Eminent Spine
Orthopedic · 126d
Cleared Mar 30, 2015
DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
K141527 · HRS
Synthes (Usa)
Orthopedic · 294d
Cleared Mar 25, 2015
Echo Bi-Metric Microplasty Line Extension
K150503 · LPH
Biomet, Inc.
Orthopedic · 27d
Cleared Mar 25, 2015
FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE
K143533 · MQV
Prosidyan, Inc.
Orthopedic · 103d
Cleared Mar 25, 2015
Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with...
K143473 · MBI
Cayenne Medical, Inc.
Orthopedic · 110d
Cleared Mar 25, 2015
VEGA Knee System, Columbus Total Knee System
K143443 · JWH
Aesculap Implants Systems, LLC
Orthopedic · 113d
Cleared Mar 25, 2015
PASS LP Spinal System
K142798 · MNH
Medicrea International SA
Orthopedic · 177d
Cleared Mar 25, 2015
INVISION TOTAL ANKLE REVISION SYSTEM
K142117 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 233d
Cleared Mar 24, 2015
Tarsa-Link Wedge Fixation System
K150368 · HRS
Life Spine
Orthopedic · 40d
Cleared Mar 24, 2015
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
K143096 · LZO
Smith & Nephew, Inc.
Orthopedic · 147d
Cleared Mar 24, 2015
Progressive Orthopedic Total Knee System
K142649 · JWH
The Progressive Orthopaedic Company, LLC
Orthopedic · 188d
Cleared Mar 24, 2015
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K141278 · PGN
Ellipse Technologies, Inc.
Orthopedic · 312d
Cleared Mar 23, 2015
Integra Laminoplasty System
K150469 · NQW
Seaspine, Inc.
Orthopedic · 28d
Cleared Mar 23, 2015
Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates...
K150099 · HRS
Synthes USA Products, LLC
Orthopedic · 62d
Cleared Mar 23, 2015
Flow-Screw
K142776 · HWC
Flow-Fx, LLC
Orthopedic · 178d
Cleared Mar 20, 2015
LITe Plate System
K150449 · KWQ
Stryker Corp.
Orthopedic · 28d
Cleared Mar 20, 2015
RESTORIS POROUS PARTIAL KNEE SYSTEM
K150410 · HRY
Mako Surgical Corporation
Orthopedic · 30d
Cleared Mar 20, 2015
Navio
K143668 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 86d