FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

Filters: Orthopedic ×
17,985 results
14401–14424 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 10, 1997
MULTITAK SS SUTURE SYSTEM
K964324 · MBI
Bonutti Research
Orthopedic · 72d
Cleared Jan 09, 1997
HERITAGE HIP SYSTEM
K963109 · JDI
Zimmer, Inc.
Orthopedic · 150d
Cleared Jan 09, 1997
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL...
K963357 · MNH
Synthes (Usa)
Orthopedic · 136d
Cleared Jan 09, 1997
SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION
K964259 · JDO
Synthes (Usa)
Orthopedic · 76d
Cleared Jan 08, 1997
PERFECTA PLASMA SPRAY HIP STEM
K964218 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 78d
Cleared Jan 02, 1997
PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL...
K963255 · JWH
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 136d
Cleared Dec 27, 1996
CORAIL
K953111 · LZO
Landos, Inc.
Orthopedic · 543d
Cleared Dec 27, 1996
DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM
K962486 · KWQ
Depuy, Inc.
Orthopedic · 184d
Cleared Dec 27, 1996
FOUNDATION KNEE SYSTEM
K964008 · JWH
Encore Orthopedics, Inc.
Orthopedic · 81d
Cleared Dec 27, 1996
WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD
K964150 · LZO
Whiteside Biomechanics, Inc.
Orthopedic · 72d
Cleared Dec 27, 1996
TRIMAX NAIL SYSTEM
K964163 · HSB
Smith & Nephew Richards, Inc.
Orthopedic · 71d
Cleared Dec 27, 1996
EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
K964262 · JDI
Exactech, Inc.
Orthopedic · 63d
Cleared Dec 20, 1996
ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM
K964215 · HRX
Smith & Nephew Endoscopy, Inc.
Orthopedic · 59d
Cleared Dec 19, 1996
OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)
K963959 · MEH
Osteonics Corp.
Orthopedic · 78d
Cleared Dec 17, 1996
SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K962894 · HRS
Synthes (Usa)
Orthopedic · 145d
Cleared Dec 16, 1996
ADVANTAGE MAPF HIP FEMORAL COMPONENT
K960643 · KWY
Biomet, Inc.
Orthopedic · 306d
Cleared Dec 16, 1996
DEPUY CANNULATED CROSS PIN SCREW SYSTEM
K963973 · JDW
Depuy, Inc.
Orthopedic · 74d
Cleared Dec 16, 1996
ACROMED CABLE/WIRE PEDICLE SCREW
K964007 · MNH
Acromed Corp.
Orthopedic · 70d
Cleared Dec 09, 1996
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
K962314 · KWP
Osteonics Corp.
Orthopedic · 175d
Cleared Dec 09, 1996
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608 · MNH
Synthes (Usa)
Orthopedic · 159d
Cleared Dec 09, 1996
KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS
K963796 · JWH
Howmedica Corp.
Orthopedic · 77d
Cleared Dec 09, 1996
ULTIMA FX FEMORAL HIP STEMS
K963885 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 74d
Cleared Dec 09, 1996
ELLIS EXTERNAL MINI-FIXATOR SYSTEM
K964458 · KTT
Link America, Inc.
Orthopedic · 32d
Cleared Dec 09, 1996
ACUMED TENSION BAND PIN
K964500 · HTY
Acu Med, Inc.
Orthopedic · 31d