FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
11041–11064 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 23, 2005
SYNTHACER
K041177 · MQV
Medartis Medizinprodukte Und...
Orthopedic · 414d
Cleared Jun 23, 2005
RESTORATION MODULAR SYSTEM
K051363 · JDI
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jun 22, 2005
ZODIAC SPINAL FIXATION SYSTEM
K050830 · KWP
Alphatec/Nexmed
Orthopedic · 82d
Cleared Jun 22, 2005
CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM
K050852 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 79d
Cleared Jun 21, 2005
ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS
K051335 · JDI
Exactech, Inc.
Orthopedic · 29d
Cleared Jun 17, 2005
POLYGRAFT BGS
K041382 · JDK
Osteobiologics, Inc.
Orthopedic · 388d
Cleared Jun 17, 2005
ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM
K043176 · HWC
Arc Surgical, LLC
Orthopedic · 213d
Cleared Jun 17, 2005
PARALLAX ACRYLIC RESIN WITH TRACERS TA
K050864 · NDN
Arthrocare Corp.
Orthopedic · 73d
Cleared Jun 17, 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
K051196 · MQP
Implex Corp.
Orthopedic · 38d
Cleared Jun 17, 2005
ZODIAC SPINAL FIXATION SYSTEM
K051286 · MNH
Alphatec/Nexmed
Orthopedic · 30d
Cleared Jun 17, 2005
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K051306 · LXT
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jun 15, 2005
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM
K051326 · HRX
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Jun 14, 2005
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM
K043548 · KWQ
Blackstone Medical, Inc.
Orthopedic · 173d
Cleared Jun 14, 2005
CD HORIZON SPINAL SYSTEM
K050809 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 75d
Cleared Jun 14, 2005
TRANS1 AXIALIF SYSTEM
K050965 · KWQ
Trans1 Incorporated
Orthopedic · 57d
Cleared Jun 14, 2005
CONSTRUX MINI PEEK VBR SYSTEM
K051246 · MQP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Jun 09, 2005
MENDEC SPINE
K042415 · NDN
Tecres S.P.A.
Orthopedic · 275d
Cleared Jun 09, 2005
STERLING INTERFERENCE SCREW ST
K050767 · HWC
Regeneration Technologies, Inc.
Orthopedic · 76d
Cleared Jun 09, 2005
BASIS VERTEBRAL BODY SPACER
K051105 · MQP
Medtronic Sofamor Danek
Orthopedic · 38d
Cleared Jun 09, 2005
AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
K051250 · MAI
Axya Medical, Inc.
Orthopedic · 24d
Cleared Jun 06, 2005
CENTERPIECE PLATE FIXATION SYSTEM
K050082 · NQW
Medtronic Sofamor Danek, Inc.
Orthopedic · 144d
Cleared Jun 03, 2005
CALLOS IMPACT AND INJECT BONE VOID FILLER
K051123 · MQV
Skeletal Kinetics, LLC
Orthopedic · 31d
Cleared May 31, 2005
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
K051086 · KRR
Smith & Nephew, Inc.
Orthopedic · 33d
Cleared May 27, 2005
BALANCE HIP SYSTEM
K050251 · KWA
Biomet, Inc.
Orthopedic · 113d