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
16153–16176 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 21, 1991
UHMWP ACETABULAR COMPONENT
K912426 · JDI
Howmedica Corp.
Orthopedic · 82d
Cleared Aug 20, 1991
MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP
K912266 · JWH
Orothmet, Inc.
Orthopedic · 90d
Cleared Aug 19, 1991
AGC REVISION KNEE PROTHESIS
K912245 · JWH
Biomet, Inc.
Orthopedic · 90d
Cleared Aug 16, 1991
OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C
K911728 · MEH
Osteonics Corp.
Orthopedic · 121d
Cleared Aug 16, 1991
MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO
K912205 · HRX
Microaire
Orthopedic · 88d
Cleared Aug 16, 1991
MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO.
K912206 · HRX
Microaire
Orthopedic · 88d
Cleared Aug 16, 1991
OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP
K912654 · MEH
Osteonics Corp.
Orthopedic · 60d
Cleared Aug 14, 1991
INTRAMEDULLARY HIP SCREW, MODIFICATION
K912162 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 90d
Cleared Aug 13, 1991
OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP
K912147 · JWH
Osteonics Corp.
Orthopedic · 90d
Cleared Aug 12, 1991
KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL
K912295 · LZO
Kinamed, Inc.
Orthopedic · 82d
Cleared Aug 09, 1991
INSIDE JOB
K912871 · HRX
3M Health Care, Ltd.
Orthopedic · 42d
Cleared Jul 30, 1991
ALTA CHANNEL PLATE CONNECTOR
K910482 · HRS
Howmedica Corp.
Orthopedic · 174d
Cleared Jul 26, 1991
GROSS HIP FEMORAL COMPONENT
K904737 · JDI
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 281d
Cleared Jul 26, 1991
FINN KNEE PROSTHESIS
K910877 · KRO
Biomet, Inc.
Orthopedic · 147d
Cleared Jul 26, 1991
MASTERPIECES MICRO SYSTEM
K910957 · HRS
Storz Instrument Co.
Orthopedic · 142d
Cleared Jul 26, 1991
OSTEONICS(R) PRT HIP STEM SERIES
K911890 · JDI
Osteonics Corp.
Orthopedic · 88d
Cleared Jul 26, 1991
BONE NAIL, KUNTSCHER
K911982 · HSD
International Hospital Supply Co.
Orthopedic · 84d
Cleared Jul 25, 1991
WYMAN SUTURE WASHER
K910186 · HTN
Acu Med, Inc.
Orthopedic · 191d
Cleared Jul 24, 1991
SOFT TISSUE SUTURE WASHER/3 HOLE WASHER
K910229 · HTN
Depuy, Inc.
Orthopedic · 187d
Cleared Jul 24, 1991
HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT
K912395 · MEH
Howmedica Corp.
Orthopedic · 57d
Cleared Jul 18, 1991
K-CAP-I, STERILE
K912762 · LYT
Westcon Orthopedics, Inc.
Orthopedic · 24d
Cleared Jul 17, 1991
TOWNLEY TOTAL KNEE (TTK)
K904448 · JWH
Biopro, Inc.
Orthopedic · 292d
Cleared Jul 16, 1991
M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST)
K911718 · JDI
Biomet, Inc.
Orthopedic · 90d
Cleared Jul 15, 1991
RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP
K911685 · JDI
Biomet, Inc.
Orthopedic · 90d