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
14689–14712 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 21, 1995
DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT
K954138 · JWH
Howmedica Corp.
Orthopedic · 81d
Cleared Nov 20, 1995
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE
K953714 · HRS
Zimmer, Inc.
Orthopedic · 103d
Cleared Nov 16, 1995
RIZA-RIBE NEEDLE (MODIFICATION)
K954882 · HRX
R-Med, Inc.
Orthopedic · 98d
Cleared Nov 15, 1995
UNITRAX V40 MODULAR ADAPTOR
K954077 · KWL
Howmedica Corp.
Orthopedic · 77d
Cleared Nov 14, 1995
RETROGRADE KNIFE
K954507 · HRX
Phx Technologies Corp.
Orthopedic · 47d
Cleared Nov 14, 1995
RETRACTOR
K954508 · HRX
Phx Technologies Corp.
Orthopedic · 47d
Cleared Nov 14, 1995
PROBE KNIFE
K954509 · HRX
Phx Technologies Corp.
Orthopedic · 47d
Cleared Nov 14, 1995
RRIANGLE KNIFE
K954510 · HRX
Phx Technologies Corp.
Orthopedic · 47d
Cleared Nov 09, 1995
CODMAN ANTERIOR CERVICAL PLATE SYSTEM
K953730 · KWQ
Johnson & Johnson Professionals, Inc.
Orthopedic · 91d
Cleared Nov 09, 1995
FMS DUO
K954465 · HRX
Future Medical Systems, Inc.
Orthopedic · 45d
Cleared Nov 08, 1995
ARTHROSCOPE
K942029 · HRX
Surgical Technologies, Inc.
Orthopedic · 561d
Cleared Nov 07, 1995
RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
K950275 · MAI
Zimmer, Inc.
Orthopedic · 288d
Cleared Nov 07, 1995
SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM
K953779 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 85d
Cleared Nov 06, 1995
COHORT(TM) ANTERIOR PLATE SYSTEM (APS)
K950011 · KWQ
Cohort Medical Products Group, Inc.
Orthopedic · 307d
Cleared Nov 06, 1995
LUBINUS SP II HIP SYSTEM
K953653 · JDG
Turnkey Intergration USA, Inc.
Orthopedic · 95d
Cleared Nov 06, 1995
SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM
K953778 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 84d
Cleared Nov 06, 1995
CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5
K953792 · LZO
U.S. Medical Products, Inc.
Orthopedic · 84d
Cleared Nov 06, 1995
PERCUTANEOUS DISCECTOMY CANNULA SYSTEM
K954014 · HRX
T. Korossurgical Instruments Corp.
Orthopedic · 73d
Cleared Nov 06, 1995
ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES
K954052 · HRX
T. Korossurgical Instruments Corp.
Orthopedic · 69d
Cleared Nov 03, 1995
DEPUY STAINLESS STEEL SET SCREW
K953650 · HWC
Depuy, Inc.
Orthopedic · 91d
Cleared Nov 03, 1995
NEXUS II FEMORAL COMPONENT
K954262 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 52d
Cleared Nov 02, 1995
AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION
K953720 · KWQ
Aesculap, Inc.
Orthopedic · 85d
Cleared Nov 02, 1995
APEX TUBING SET
K954440 · HRX
Linvatec Corp.
Orthopedic · 38d
Cleared Oct 31, 1995
PEBA ANCHOR (MULTIPLE SIZES)
K951451 · MBI
Orthopaedic Biosystems, Ltd.
Orthopedic · 216d