Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Orthopedic ×
17,985 results
16105–16128 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 07, 1991
SPIKED WASHER
K914472 · HTN
Synthes (Usa)
Orthopedic · 31d
Cleared Nov 05, 1991
PGK STEREOTACTIC DEVICE
K911974 · HRX
Northern Virginia Radiology and...
Orthopedic · 186d
Cleared Oct 29, 1991
AESCULAP TITANIUM BONE SCREWS
K913415 · HWC
Aesculap, Inc.
Orthopedic · 90d
Cleared Oct 25, 1991
RAY SACRAL FIXATION SYSTEM
K904520 · KWP
Danek Medical, Inc.
Orthopedic · 387d
Cleared Oct 25, 1991
FREEMAN-SAMUELSON MODULAR TOTAL KNEE REPLACEMENT
K911972 · JWH
Intermedics Orthopedics
Orthopedic · 175d
Cleared Oct 24, 1991
CROSSLINK PLATE
K911307 · KWP
Danek Medical, Inc.
Orthopedic · 213d
Cleared Oct 23, 1991
P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL
K914439 · HSX
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 19d
Cleared Oct 21, 1991
LIMA RPS SHOULDER
K913282 · HSD
Turnkey Intergration USA, Inc.
Orthopedic · 89d
Cleared Oct 18, 1991
AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT
K912894 · JWH
Orthomet, Inc.
Orthopedic · 109d
Cleared Oct 18, 1991
HYBRID FIT TOTAL HIP SYSTEM
K913246 · JDI
Kirschner Medical Corp.
Orthopedic · 88d
Cleared Oct 17, 1991
OSTEO BONE PLATED
K913271 · HRS
Fred C. Bryson
Orthopedic · 86d
Cleared Oct 15, 1991
TRUE/FLEX TIBIAL RODS WITH CAP
K912710 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 118d
Cleared Oct 15, 1991
FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM
K913461 · JDR
Neoligaments, Ltd.
Orthopedic · 71d
Cleared Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)
K912369 · MEH
Biomet, Inc.
Orthopedic · 135d
Cleared Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
K912370 · MEH
Biomet, Inc.
Orthopedic · 135d
Cleared Oct 11, 1991
NATURAL POROUS HIP SYSTEM
K913060 · JDI
Intermedics Orthopedics
Orthopedic · 93d
Cleared Oct 11, 1991
KINEMAX PLUS TIBIAL INSERT
K913188 · JWH
Howmedica Corp.
Orthopedic · 85d
Cleared Oct 11, 1991
APR II NON-POROUS HIP STEM
K913208 · JDI
Intermedics Orthopedics
Orthopedic · 84d
Cleared Oct 10, 1991
ARTHRO-FLOW IRRIGATION 2 SYSTEM
K913028 · HRX
Davol, Inc.
Orthopedic · 93d
Cleared Oct 04, 1991
SIMMONS PLATING SYSTEM
K910681 · KWQ
Smith & Nephew Richards, Inc.
Orthopedic · 231d
Cleared Oct 04, 1991
AMSET(TM) BONE SCREW
K911768 · HWC
Advanced Med/Surg, Inc.
Orthopedic · 168d
Cleared Oct 04, 1991
HA MCCUTCHEN SLT HIP SYSTEM
K912452 · MEH
Dow Corning Wright
Orthopedic · 123d
Cleared Oct 04, 1991
DIMENSION-HA HIP PROSTHESIS
K912922 · MEH
Kirschner Medical Corp.
Orthopedic · 93d
Cleared Oct 04, 1991
CONCEPT MICROMILL
K912957 · HRX
Concept, Inc.
Orthopedic · 88d