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
14257–14280 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 17, 1997
HSW GMBH ARTHROSCOPE
K962075 · HRX
Henke Sass Wolf of America, Inc.
Orthopedic · 234d
Cleared Jan 17, 1997
OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY
K964304 · MNH
Osteonics Corp.
Orthopedic · 80d
Cleared Jan 16, 1997
SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM
K950099 · MNH
Buckman Co., Inc.
Orthopedic · 737d
Cleared Jan 16, 1997
MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA
K964350 · JDI
Intermedics Orthopedics
Orthopedic · 77d
Cleared Jan 16, 1997
KINAMED PROFIX SYSTEM
K964362 · HRS
Kinamed, Inc.
Orthopedic · 76d
Cleared Jan 14, 1997
MAYO HIP PROSTHESIS
K943230 · LPH
Mayo Clinic
Orthopedic · 923d
Cleared Jan 14, 1997
METAL ACETABULAR COMPONENT
K964227 · LPH
Encore Orthopedics, Inc.
Orthopedic · 83d
Cleared Jan 14, 1997
BRIDGE LONG STEM FEMORAL COMPONENT
K964249 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 82d
Cleared Jan 14, 1997
ALPHA POSTERIOR SPINAL SYSTEM
K964275 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 81d
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