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
14281–14304 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 16, 1996
ADVANTAGE MAPF HIP FEMORAL COMPONENT
K960643 · KWY
Biomet, Inc.
Orthopedic · 306d
Cleared Dec 16, 1996
DEPUY CANNULATED CROSS PIN SCREW SYSTEM
K963973 · JDW
Depuy, Inc.
Orthopedic · 74d
Cleared Dec 16, 1996
ACROMED CABLE/WIRE PEDICLE SCREW
K964007 · MNH
Acromed Corp.
Orthopedic · 70d
Cleared Dec 09, 1996
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
K962314 · KWP
Osteonics Corp.
Orthopedic · 175d
Cleared Dec 09, 1996
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608 · MNH
Synthes (Usa)
Orthopedic · 159d
Cleared Dec 09, 1996
KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS
K963796 · JWH
Howmedica Corp.
Orthopedic · 77d
Cleared Dec 09, 1996
ULTIMA FX FEMORAL HIP STEMS
K963885 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 74d
Cleared Dec 09, 1996
ELLIS EXTERNAL MINI-FIXATOR SYSTEM
K964458 · KTT
Link America, Inc.
Orthopedic · 32d
Cleared Dec 09, 1996
ACUMED TENSION BAND PIN
K964500 · HTY
Acu Med, Inc.
Orthopedic · 31d
Cleared Dec 05, 1996
CD HORIZON SPINAL SYSTEM
K961633 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 220d
Cleared Dec 05, 1996
GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
K962557 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 157d
Cleared Dec 05, 1996
HUMERUS WIRES
K964243 · HSB
Compagnie Financiere & Medicale (Cf&M)
Orthopedic · 42d
Cleared Dec 04, 1996
CEMENT-ON FEMORAL STEM
K963709 · JWH
Biomet, Inc.
Orthopedic · 79d
Cleared Nov 27, 1996
KONSTRUCT PATELLAR COMPONENT
K960856 · JWH
Biomet, Inc.
Orthopedic · 271d
Cleared Nov 27, 1996
ISOLA PEDIATRIC COMPONENTS
K962984 · KWP
Acromed Corp.
Orthopedic · 118d
Cleared Nov 27, 1996
KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE
K963029 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 114d
Cleared Nov 27, 1996
REVISION HIP SYSTEM
K963486 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 85d
Cleared Nov 27, 1996
CD HORIZON ANTERIOR SPINAL SYSTEM
K963655 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 76d
Cleared Nov 27, 1996
SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM
K963798 · HRS
Synthes (Usa)
Orthopedic · 65d
Cleared Nov 27, 1996
MINIFIX
K964094 · KTT
Ferguson Medical
Orthopedic · 47d
Cleared Nov 25, 1996
ANSPACH SUTURE ANCHOR (MODIFIED)
K963686 · MBI
The Anspach Effort, Inc.
Orthopedic · 74d
Cleared Nov 25, 1996
BLOCK STOP WIRES
K964087 · HTY
Ferguson Medical
Orthopedic · 45d
Cleared Nov 18, 1996
HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)
K955733 · HWC
Depuy, Inc.
Orthopedic · 336d
Cleared Nov 15, 1996
CANCELLOUS SCREW WASHER
K963420 · HTN
Orthopaedic Biosystems, Ltd.
Orthopedic · 77d