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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,816 results
11017–11040 of 17,816
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared May 27, 2005
ARTHREX BIO-PIN
K050259 · HTY
Arthrex, Inc.
Orthopedic · 113d
Cleared May 27, 2005
CO VERTEBRAL BODY REPLACEMENT
K050348 · MQP
Scient'X
Orthopedic · 105d
Cleared May 27, 2005
FORMAGRAFT COLLAGEN BONE GRAFT MATRIX
K050789 · MQV
R and D Medical, LLC
Orthopedic · 60d
Cleared May 27, 2005
PEEK CAS
K050861 · MQP
Interpore Cross Intl.
Orthopedic · 52d
Cleared May 27, 2005
MAXLOCK
K050868 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 51d
Cleared May 27, 2005
NEWDEAL ANKLE NAIL
K050882 · HSB
New Deal, S.A.
Orthopedic · 50d
Cleared May 27, 2005
MERETE DUOTHREADTM BONE SCREW
K050924 · HWC
Merete Medical GmbH
Orthopedic · 44d
Cleared May 27, 2005
ENCORE REVERSE SHOULDER PROSTHESIS
K051075 · PHX
Encore Medical, L.P.
Orthopedic · 30d
Cleared May 26, 2005
EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
K050766 · HWE
Zimmer Trabecular
Orthopedic · 62d
Cleared May 26, 2005
XPAND CORPECTOMY SPACER
K050850 · MQP
Globus Medical, Inc.
Orthopedic · 52d