FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
12553–12576 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Sep 24, 2001
AOS MODULAR FEMORAL NAIL
K012190 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 73d
Cleared Sep 24, 2001
XIA STAINLESS STEEL SYSTEM
K012870 · KWP
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Sep 20, 2001
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X...
K000122 · MQV
Neucoll, Inc.
Orthopedic · 611d