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
11233–11256 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 18, 2005
COMPRESSION STAPLE AND SIMPLE STAPLE
K043059 · JDR
Wrightmedicaltechnologyinc
Orthopedic · 74d
Cleared Jan 14, 2005
CONCORD Radiopaque Bone Cement
K042168 · NDN
Globus Medical, Inc.
Orthopedic · 158d
Cleared Jan 14, 2005
CABLING SYSTEM TROCHANTER HOOK
K043252 · JDQ
Smith & Nephew, Inc.
Orthopedic · 52d
Cleared Jan 14, 2005
TRIMED OSTEOTOMY PLATE
K043263 · HRS
TriMed, Inc.
Orthopedic · 51d
Cleared Jan 14, 2005
ISSYS PEDICLE SCREW SYSTEM
K043522 · KWP
Custom Spine, Inc.
Orthopedic · 25d
Cleared Jan 14, 2005
TAPERLOC 12/14 TAPER FEMORAL COMPONENTS
K043537 · LPH
Biomet, Inc.
Orthopedic · 23d
Cleared Jan 12, 2005
SMITH & NEPHEW HYBRID KNEE FEMORAL
K042896 · NPJ
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Jan 12, 2005
TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT
K042993 · JWH
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Jan 12, 2005
SMITH & NEPHEW VIDEOARTHROSCOPE
K043395 · HRX
Smith & Nephew, Inc.
Orthopedic · 33d
Cleared Jan 12, 2005
MODIFICATION TO XIA SPINAL SYSTEM
K043473 · KWP
Stryker Spine
Orthopedic · 27d
Cleared Jan 10, 2005
DENALI SPINE SYSTEM
K042635 · KWP
K2m, LLC
Orthopedic · 105d
Cleared Jan 07, 2005
5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN
K033856 · KTT
Peter Stevens, MD
Orthopedic · 393d
Cleared Jan 07, 2005
SOLAR 2 ANATOMIC SHOULDER
K040432 · HSD
Stryker Orthopaedics
Orthopedic · 323d
Cleared Jan 07, 2005
X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
K041824 · HRX
Future Medical Systems, SA
Orthopedic · 185d
Cleared Jan 07, 2005
GLAXY 3.2 SPINAL SYSTEM
K043020 · KWP
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Jan 07, 2005
SYNTHES (USA) CHRONOS
K043045 · MQV
Synthes (Usa)
Orthopedic · 64d
Cleared Jan 07, 2005
BF+
K043347 · MQV
Ldr Spine USA
Orthopedic · 32d
Cleared Jan 07, 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043566 · MQP
Medtronic Sofamor Danek
Orthopedic · 11d
Cleared Jan 05, 2005
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
K043310 · HWE
Synthes (Usa)
Orthopedic · 35d
Cleared Dec 29, 2004
TITANIUM MESH IMPLANT
K041407 · MQP
Interpore Cross Intl.
Orthopedic · 216d
Cleared Dec 29, 2004
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
K042713 · MQP
Spine Next America Corporation
Orthopedic · 90d
Cleared Dec 29, 2004
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4
K042714 · MQP
Spine Next America Corporation
Orthopedic · 96d
Cleared Dec 29, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043561 · MQP
Medtronic Sofamor Danek
Orthopedic · 2d
Cleared Dec 28, 2004
SPACEVISION CAGE SYSTEM
K042930 · MQP
Spine Vision, Inc.
Orthopedic · 67d