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
11281–11304 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 16, 2005
SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
K042899 · HTO
Synthes (Usa)
Orthopedic · 147d
Cleared Mar 16, 2005
AEQUALIS REVERSED SHOULDER PROSTHESIS
K050316 · PHX
Tornier
Orthopedic · 35d
Cleared Mar 14, 2005
SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
K042515 · JWH
Smith & Nephew, Inc.
Orthopedic · 179d
Cleared Mar 14, 2005
PINNACLE CONSTRAINED ACETABULAR LINERS
K043058 · KWZ
Depuy, Inc.
Orthopedic · 129d
Cleared Mar 14, 2005
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
K043570 · HSX
Conformis, Inc.
Orthopedic · 77d
Cleared Mar 14, 2005
AOS HUMERAL NAIL
K050241 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 40d
Cleared Mar 14, 2005
TAMARACK ANTERIOR THORACOLUNBAR
K050390 · KWQ
Alphatec/Nexmed
Orthopedic · 26d
Cleared Mar 14, 2005
MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM
K050457 · KTT
Merete Medical GmbH
Orthopedic · 19d
Cleared Mar 14, 2005
INTEGRA BONE FIXATION SYSTEM
K050492 · HRS
Integra Lifesciences Corp.
Orthopedic · 14d
Cleared Mar 11, 2005
SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT
K041825 · JWH
Smith & Nephew, Inc.
Orthopedic · 247d
Cleared Mar 11, 2005
MODIFICATION TO DYNESYS SPINAL SYSTEM
K043565 · NQP
Zimmer Spine, Inc.
Orthopedic · 74d
Cleared Mar 10, 2005
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
K043526 · LGF
Noble Fiber Technologies, Inc.
Orthopedic · 79d
Cleared Mar 08, 2005
ARCOMXL POLYETHYLENE LINERS
K042051 · LPH
Biomet, Inc.
Orthopedic · 221d
Cleared Mar 07, 2005
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM...
K043101 · JWH
Zimmer, Inc.
Orthopedic · 118d
Cleared Mar 07, 2005
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM
K043578 · MNH
Solco Biomedical Co., Ltd.
Orthopedic · 69d
Cleared Mar 07, 2005
MODIFICATION TO: INION OTPS BIODEGRADABLE PIN
K050275 · HTY
Inion , Ltd.
Orthopedic · 28d
Cleared Mar 04, 2005
HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM
K050048 · KTT
Howmedica Osteonics Corp.
Orthopedic · 53d
Cleared Mar 04, 2005
SYNTHES (USA) LCP MODULAR FOOT PLATES
K050110 · HRS
Synthes (Usa)
Orthopedic · 45d
Cleared Mar 02, 2005
STRYKER SPINE TRIO PS
K043180 · MNH
Stryker Spine
Orthopedic · 105d
Cleared Mar 02, 2005
THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER
K050227 · MBI
Linvatec Corp.
Orthopedic · 29d
Cleared Feb 25, 2005
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
K050041 · JDQ
Synthes (Usa)
Orthopedic · 49d
Cleared Feb 24, 2005
EPIPHYSIS SCREW
K043410 · HWC
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 76d
Cleared Feb 18, 2005
INTERGRO DBM
K031399 · MQV
Interpore Cross Intl.
Orthopedic · 655d
Cleared Feb 18, 2005
STANSION MATRIX
K042600 · MQP
Spineworks, LLC
Orthopedic · 148d