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
13897–13920 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 16, 1998
OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT
K972967 · JWH
Osteonics Corp.
Orthopedic · 158d
Cleared Jan 16, 1998
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW
K973309 · HWC
Vilex, Inc.
Orthopedic · 135d
Cleared Jan 16, 1998
TIMESH SYSTEM
K974017 · HRS
Sofamor Danek USA,Inc.
Orthopedic · 86d
Cleared Jan 13, 1998
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K973923 · KWQ
Ebi Electro Biology
Orthopedic · 90d
Cleared Jan 12, 1998
ENCORE LINEAR HIP
K972791 · JDI
Encore Orthopedics, Inc.
Orthopedic · 168d
Cleared Jan 12, 1998
ORBITAL RECONSTRUCTION PLATES
K973982 · HRS
Howmedica, Inc.
Orthopedic · 84d
Cleared Jan 12, 1998
ENCORE LINEAR POROUS COATED HIP
K974294 · LPH
Encore Orthopedics, Inc.
Orthopedic · 59d
Cleared Jan 12, 1998
OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS
K974434 · HRY
Osteonics Corp.
Orthopedic · 49d
Cleared Jan 08, 1998
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K973868 · KWP
Osteotech, Inc.
Orthopedic · 90d
Cleared Jan 06, 1998
CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL
K973837 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 06, 1998
BIOABSORBABLE BANKART TACK
K973849 · MAI
Hogan & Hartson
Orthopedic · 90d
Cleared Jan 05, 1998
DRG LARGE SCREW SYSTEM
K973810 · HWC
Dolphin Medical Technologies, Inc.
Orthopedic · 90d
Cleared Jan 05, 1998
PRE-POWDERED NITRILE EXAMINATION GLOVES
K974442 · LZY
P.T. Latexindo Tobaperkasa
Orthopedic · 41d
Cleared Jan 02, 1998
FOUNDATION FRACTURE STEM
K973809 · JDI
Encore Orthopedics, Inc.
Orthopedic · 88d
Cleared Dec 29, 1997
AESCULAP HILAN MOTOR SYSTEM
K973736 · HWE
Aesculap, Inc.
Orthopedic · 89d
Cleared Dec 24, 1997
OMEGA 21 SYSTEM
K973683 · MNH
Ebi Electro Biology
Orthopedic · 89d
Cleared Dec 24, 1997
VERSYS HIP SYSTEM BEADED HIP PROSTHESIS
K973714 · LPH
Zimmer, Inc.
Orthopedic · 86d
Cleared Dec 23, 1997
DISTAL CENTRALIZER, EXETER II HIP SYSTEM
K974054 · JDI
Howmedica, Inc.
Orthopedic · 57d
Cleared Dec 19, 1997
THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM
K973595 · JWH
Corin USA
Orthopedic · 88d
Cleared Dec 19, 1997
NATURAL-HIP POROUS STEM WITH OFFSET
K973675 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
NATURAL-HIP COCR OFFSET STEM
K973681 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
REVELATION POROUS HIP STEM
K973685 · LPH
Encore Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
ORTHOFIX FEMORAL NAILING SYTEM
K973944 · HSB
Orthofix Srl
Orthopedic · 64d
Cleared Dec 19, 1997
CERCLAGE CABLE WITH HEX BUTTON
K974016 · JDQ
Pioneer Surgical Technology
Orthopedic · 58d