FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
14425–14448 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Nov 14, 1996
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K960652 · HWC
Linvatec Corp.
Orthopedic · 273d
Cleared Nov 14, 1996
SYNTHES STERILE DRILL BITS
K962913 · HWE
Synthes (Usa)
Orthopedic · 111d
Cleared Nov 14, 1996
DURACON POSTERIOR FEMORAL SPACER
K963242 · JWH
Howmedica Corp.
Orthopedic · 87d
Cleared Nov 14, 1996
EXACTECH ALL POLY ACETABULAR CUP
K963313 · JDI
Exactech, Inc.
Orthopedic · 84d
Cleared Nov 14, 1996
DEPUY MOTECH PEAK FIXATION SYSTEM
K963350 · HWC
Depuy, Inc.
Orthopedic · 80d
Cleared Nov 14, 1996
KSEA LARGE JOINT ARTHROSCOPY SET
K963524 · HRX
Karl Storz Endoscopy
Orthopedic · 71d
Cleared Nov 14, 1996
ACROMED PEDICLE SCREW
K963639 · KWP
Acromed Corp.
Orthopedic · 63d
Cleared Nov 13, 1996
EZ-FIX CANNULATED SCREW SYSTEM
K962706 · HWC
Biodynamic Technologies, Inc.
Orthopedic · 124d
Cleared Nov 13, 1996
LM BONE ANCHOR
K963288 · MBI
Li Medical Technologies, Inc.
Orthopedic · 84d