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
11929–11952 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 11, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K031823 · MQP
Implex Corp.
Orthopedic · 28d
Cleared Jul 10, 2003
EBI XFIX OPTIROM KNEE FIXATOR
K031093 · KTT
Ebi, L.P.
Orthopedic · 94d
Cleared Jul 08, 2003
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
K031555 · LXC
Synthes (Usa)
Orthopedic · 50d
Cleared Jul 02, 2003
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM
K031276 · KWQ
Synthes (Usa)
Orthopedic · 71d
Cleared Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · HWC
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Jul 01, 2003
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
K031734 · JDI
Biomet, Inc.
Orthopedic · 27d
Cleared Jul 01, 2003
DEPUY CERAMIC FEMORAL HEADS
K031803 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared Jun 27, 2003
SMISSON STABILIZATION SYSTEM
K021979 · KWQ
Smisson-Cartledge
Orthopedic · 375d
Cleared Jun 27, 2003
ORIA CLARIS
K023378 · MNH
Ortho Tec, LLC
Orthopedic · 262d
Cleared Jun 27, 2003
BLACKSTONE SURGICAL TITANIUM MESH
K030744 · MQP
Blackstone Medical, Inc.
Orthopedic · 109d
Cleared Jun 27, 2003
SUSTAIN SPACER
K031302 · MQP
Globus Medical, Inc.
Orthopedic · 64d
Cleared Jun 27, 2003
EBI P148 SPINAL FIXATION SYSTEM
K031423 · MNH
Ebi, L.P.
Orthopedic · 52d
Cleared Jun 27, 2003
U&I, OPTIMA, SPINAL SYSTEM
K031585 · MNH
U&I Corp., America
Orthopedic · 37d
Cleared Jun 27, 2003
CD HORIZON SPINAL SYSTEM
K031655 · MNI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jun 27, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031888 · MNI
Medtronic Sofamor Danek
Orthopedic · 9d
Cleared Jun 26, 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581 · MNH
Blackstone Medical, Inc.
Orthopedic · 122d
Cleared Jun 26, 2003
MINILOK QUICKANCHOR PLUS
K030995 · HWC
Mitek Worldwide
Orthopedic · 87d
Cleared Jun 26, 2003
RAPIDFIRE SELF DRILLING SCREWS
K031751 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 21d
Cleared Jun 25, 2003
EBI XFIX DFS SYSTEM
K031645 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared Jun 24, 2003
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
K030875 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 96d
Cleared Jun 24, 2003
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
K031154 · JDW
Sintea Biotech, Inc.
Orthopedic · 74d
Cleared Jun 24, 2003
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
K031572 · LPH
Zimmer, Inc.
Orthopedic · 35d
Cleared Jun 24, 2003
U & I AMERICA SPINAL HOOK SYSTEM
K031595 · KWP
U&I Corp., America
Orthopedic · 34d
Cleared Jun 24, 2003
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
K031725 · KTT
Synthes (Usa)
Orthopedic · 21d