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
11137–11160 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 24, 2005
CD HORIZON SPINAL SYSTEM
K050439 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Mar 24, 2005
SYNTHES VECTRA SYSTEM
K050451 · KWQ
Synthes Spine Co.Lp
Orthopedic · 30d
Cleared Mar 21, 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K043488 · NKB
Medtronic Sofamor Danek
Orthopedic · 94d
Cleared Mar 21, 2005
MODIFICATION TO: RESTORATION MODULAR SYSTEM
K050138 · JDI
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Mar 21, 2005
STRYKER LOCKED PLATING SYSTEM
K050512 · HRS
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Mar 21, 2005
MODIFICATION TO: ARTHREX V-TAK
K050634 · HWC
Arthrex, Inc.
Orthopedic · 12d
Cleared Mar 17, 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
K040262 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 407d
Cleared Mar 17, 2005
STABILIZATION SCREW
K050346 · HWC
New Deal, S.A.
Orthopedic · 34d
Cleared Mar 16, 2005
EXCIA TOTAL HIP SYSTEM
K042344 · LWJ
Aesculap, Inc.
Orthopedic · 198d
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