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
15193–15216 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 27, 1995
EXTERNAL FIXATOR
K943857 · JEC
Acu Med, Inc.
Orthopedic · 172d
Cleared Jan 27, 1995
CONSENUS HIP SYSTEM -- ACETABULAR REAMER
K945186 · HWE
U.S. Medical Products, Inc.
Orthopedic · 95d
Cleared Jan 27, 1995
CONSENSUS HIP SYSTEM -- CALCAR PLANER
K945189 · HWE
U.S. Medical Products, Inc.
Orthopedic · 95d
Cleared Jan 27, 1995
CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER
K945208 · HWE
U.S. Medical Products, Inc.
Orthopedic · 94d
Cleared Jan 24, 1995
ARTHROSCOPE
K944842 · HRX
5 Star Medical, Inc.
Orthopedic · 116d
Cleared Jan 24, 1995
DYONICS FIXATION SCREWS
K945182 · HWC
Smith & Nephew Dyonics, Inc.
Orthopedic · 92d
Cleared Jan 20, 1995
TSRH SPINAL SCREWS
K932029 · MNH
Sofamor Danek Mfg., Inc.
Orthopedic · 633d
Cleared Jan 20, 1995
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K943853 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 165d
Cleared Jan 19, 1995
HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT
K940307 · JDI
Howmedica, Inc.
Orthopedic · 360d
Cleared Jan 19, 1995
S.T.E.P. UNI-KNEE
K940389 · HRY
S.T.E.P. Orthopaedics, Inc.
Orthopedic · 358d
Cleared Jan 19, 1995
SENTRY TOTAL HIP
K945089 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD
K945090 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
P.C.A.PRIMARY HIP- CEMENTLESS USE
K945092 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
P.C.A. E-SERIES HIP- CEMENTLESS USE
K945093 · LZO
Howmedica, Inc.
Orthopedic · 94d
Cleared Jan 19, 1995
HNR-PC HIP
K945094 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
APC FEMORAL COMPONENT
K945095 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
CDH HIP STEM
K945096 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 18, 1995
HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM
K930836 · KTT
Howmedica Corp.
Orthopedic · 700d
Cleared Jan 18, 1995
KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM
K936274 · JWH
Kirschner Medical Corp.
Orthopedic · 384d
Cleared Jan 18, 1995
CTS RELIEF KIT
K941651 · HRX
Linvatec Corp.
Orthopedic · 288d
Cleared Jan 18, 1995
HOWMEDICA ALUMINA FEMORAL HEAD
K945091 · LZO
Howmedica Corp.
Orthopedic · 93d
Cleared Jan 17, 1995
EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS
K933610 · JWH
Exactech, Inc.
Orthopedic · 539d
Cleared Jan 17, 1995
ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT
K941755 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 284d
Cleared Jan 17, 1995
THE KARL STORZ ARTHROPUMP
K942298 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 250d