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
8497–8520 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 29, 2010
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K102423 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 65d
Cleared Oct 27, 2010
FM-02 BONE GRAFT SUBSTITUTE
K102545 · MQV
Orthovita, Inc.
Orthopedic · 54d
Cleared Oct 22, 2010
VANGUARD 360 REVISION KNEE SYSTEM
K093293 · JWH
Biomet, Inc.
Orthopedic · 366d
Cleared Oct 22, 2010
CLAVICLE LOCKING PLATE SYSTEM
K100944 · HRS
Newclip Technics
Orthopedic · 199d
Cleared Oct 22, 2010
PIONEER SPINOUS PROCESS FUSION PLATE
K101525 · KWP
Pioneer Surgical Technology
Orthopedic · 142d
Cleared Oct 22, 2010
ARTHREX PUSHLOCK ANCHORS
K101679 · MAI
Arthrex, Inc.
Orthopedic · 129d
Cleared Oct 22, 2010
QUANTUM RING FIXATION SYSTEM MODEL ISF
K101759 · KTT
Quantum Medical Concepts, LLC
Orthopedic · 121d
Cleared Oct 22, 2010
KYPHON ANCHOR FACET SCREW SYSTEM
K101765 · MRW
Medtronic Spine, LLC
Orthopedic · 121d
Cleared Oct 21, 2010
EXACTECH GPS
K100742 · OLO
Blue Ortho
Orthopedic · 219d
Cleared Oct 21, 2010
T2 XVBR 1.5 SPINAL SYSTEM
K100976 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 196d
Cleared Oct 21, 2010
ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM
K102262 · MBI
Arthrocare Corp.
Orthopedic · 72d
Cleared Oct 20, 2010
CONTOURS VSP III VOLAR PLATING SYSTEM
K101936 · HRS
Orthofix, Inc.
Orthopedic · 100d
Cleared Oct 20, 2010
INTRAFIX TIBIAL SHEATH
K102443 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 55d
Cleared Oct 20, 2010
VIPER SPINE SYSTEM
K102701 · NKB
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Oct 20, 2010
PIONEER CANNULATED SCREW SYSTEM
K102903 · HWC
Pioneer Surgical Technology, Inc.
Orthopedic · 20d
Cleared Oct 19, 2010
BIO-MODULAR REVERSE SHOLDER
K093803 · PHX
Biomet Manufacturing Corp
Orthopedic · 312d
Cleared Oct 18, 2010
KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP
K093471 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 346d
Cleared Oct 18, 2010
MODIFICATION TO:EXPEDIUM SPINE SYSTEM
K101933 · NKB
Depuy Spine, Inc.
Orthopedic · 98d
Cleared Oct 15, 2010
KAPSS SPINAL SYSTEM
K093833 · MNI
Robert Reid, Inc.
Orthopedic · 305d
Cleared Oct 15, 2010
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
K102331 · MNI
Ldr Spine USA
Orthopedic · 59d
Cleared Oct 14, 2010
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
K101848 · KWQ
Spinal Elements, Inc.
Orthopedic · 105d
Cleared Oct 14, 2010
KYPHON XPANDER II INFLATABLE BONE TAMP
K101864 · HRX
Medtronic
Orthopedic · 104d
Cleared Oct 13, 2010
SMALL PLATEAU SPACER SYSTEM
K093093 · ODP
Life Spine
Orthopedic · 377d
Cleared Oct 12, 2010
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
K101700 · HWC
Extremity Medical, LLC
Orthopedic · 117d