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
16945–16968 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 24, 1986
FASCICULATED I ROD
K863215
The Deca Co.
Orthopedic · 126d
Cleared Dec 24, 1986
FASCICULATED BOAT ROD
K863239
The Deca Co.
Orthopedic · 124d
Cleared Dec 24, 1986
FASCICULATED S ROD
K863271
The Deca Co.
Orthopedic · 121d
Cleared Dec 22, 1986
OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM
K862837 · HSX
Osteonics Corp.
Orthopedic · 150d
Cleared Dec 19, 1986
OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM
K863668 · JWH
Osteonics Corp.
Orthopedic · 92d
Cleared Dec 18, 1986
MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM
K864403 · LXT
Howmedica Corp.
Orthopedic · 38d
Cleared Dec 18, 1986
MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE.
K864631
Downs Surgical , Ltd.
Orthopedic · 23d
Cleared Dec 18, 1986
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
K864633 · HWC
Howmedica Corp.
Orthopedic · 23d
Cleared Dec 16, 1986
OEC DESIGN ORTHOPEDIC CAST HEEL
K864092 · LGF
Military Engineering, Inc.
Orthopedic · 56d
Cleared Dec 16, 1986
SEGMENTAL SPINAL INSTRUMENTATION SYSTEM
K864337
Kirschner Medical Corp.
Orthopedic · 42d
Cleared Dec 15, 1986
ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT
K862017 · HRX
Dyonics, Inc.
Orthopedic · 201d
Cleared Dec 15, 1986
LEG HOLDER
K864476 · HRX
American Container Technology, Inc.
Orthopedic · 32d
Cleared Dec 15, 1986
CANCELLOUS BONE SCREW
K864626 · HWC
Dow Corning Wright
Orthopedic · 20d
Cleared Dec 12, 1986
MODIFIED SYNATOMIC KNEE PATELLA PROSTHESIS
K863667 · JWH
Depuy, Inc.
Orthopedic · 85d
Cleared Dec 09, 1986
HOWSE II TOTAL HIP REPLACEMENT SYSTEM
K864508
Johnson & Johnson Professionals, Inc.
Orthopedic · 25d
Cleared Dec 02, 1986
MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME
K863805 · JWH
Zimmer, Inc.
Orthopedic · 63d
Cleared Nov 26, 1986
RAYLOR(TM) DEPTH GAUGE
K864426 · HTJ
Cedar Surgical, Inc.
Orthopedic · 16d
Cleared Nov 25, 1986
OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE
K864372
Osteonics Corp.
Orthopedic · 20d
Cleared Nov 25, 1986
LP ARTHROSCOPIC THIGH HOLDING DEVICE
K864513 · HRX
Twin Falls Orthopedic Associates, P.A.
Orthopedic · 12d
Cleared Nov 24, 1986
WILLIAMS ORTHOPAEDIC SURGICAL INSTRUMENTS
K864340
Buckman Co., Inc.
Orthopedic · 20d
Cleared Nov 24, 1986
RAYLOR(TM) MALLET
K864422 · HWA
Cedar Surgical, Inc.
Orthopedic · 14d
Cleared Nov 24, 1986
RAYLOR(TM) OSTEOTOMES
K864423
Cedar Surgical, Inc.
Orthopedic · 14d
Cleared Nov 20, 1986
HALL DUNBAR DRILL GUIDE SYSTEM
K864163 · HRX
Hall Surgical, Division of Zimmer, Inc.
Orthopedic · 28d
Cleared Nov 19, 1986
P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUG
K863854
Precision Medical Devices, Inc.
Orthopedic · 48d