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
12769–12792 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 18, 2001
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
K012961 · JDI
Sulzer Orthopedics, Inc.
Orthopedic · 44d
Cleared Oct 17, 2001
THEKEN SMALL CEMENT RESTRICTOR
K012278 · JDK
Theken Surgical,Llc
Orthopedic · 90d
Cleared Oct 16, 2001
VBR
K012254 · MQP
Osteotech, Inc.
Orthopedic · 90d
Cleared Oct 16, 2001
VANGUARD REPROCESSED ARTHROSCOPIC BLADES
K012346 · HRX
Vanguard Medical Concepts, Inc.
Orthopedic · 84d
Cleared Oct 12, 2001
BIOCUFF,C, MODELS 236018, 236028, 236036
K013057 · MAI
Bionx Implants, Inc.
Orthopedic · 30d
Cleared Oct 11, 2001
EPOCA CUSTOM OFFSET SHOULDER SYSTEM
K010869 · KWT
Argomedical AG
Orthopedic · 202d
Cleared Oct 10, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 229d
Cleared Oct 10, 2001
DURACON PS LIPPED TIBIAL INSERT
K012172 · JWH
Howmedica Osteonics
Orthopedic · 90d
Cleared Oct 10, 2001
DISCOVERY ELBOW
K013042 · JDC
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 09, 2001
MONARCH SPINAL SYSTEMS
K013294 · MNH
Depuyacromed
Orthopedic · 7d
Cleared Oct 09, 2001
TIMX SPINAL SYSTEMS
K013295 · MNH
Depuyacromed
Orthopedic · 7d
Cleared Oct 09, 2001
MOSS MIAMI SPINAL SYSTEMS
K013296 · MNH
Depuyacromed
Orthopedic · 7d
Cleared Oct 05, 2001
ISOLA SPINAL SYSTEMS
K012971 · MNH
Depuyacromed
Orthopedic · 30d
Cleared Oct 04, 2001
MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING...
K012967 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Oct 04, 2001
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
K013014 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 03, 2001
PRO-FEMUR
K012091 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Oct 01, 2001
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · JDR
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Sep 28, 2001
VERTEX RECONSTRUCTION SYSTEM
K003780 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 295d
Cleared Sep 28, 2001
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
K012114 · HRS
Synthes (Usa)
Orthopedic · 84d
Cleared Sep 28, 2001
DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
K012173 · KWP
Sulzer Spine-Tech
Orthopedic · 78d
Cleared Sep 28, 2001
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
K012270 · JDW
Stryker Endoscopy
Orthopedic · 71d
Cleared Sep 27, 2001
PF2
K012062 · KTT
Fixano SA
Orthopedic · 87d
Cleared Sep 27, 2001
RADIOFIX
K012078 · KTT
Fixano SA
Orthopedic · 87d
Cleared Sep 26, 2001
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
K012866 · JWH
Implex Corp.
Orthopedic · 30d