FDA.report

510(k) K951266

Device
Amset R-f System
Applicant
ADVANCED SPINE TECHNOLOGY, INC.
510(k) number
K951266
Product code
MNH
Decision
Substantially Equivalent for Some Indications (SN)
Decision date
1995-11-21
Date received
1995-03-21
Regulation
888.3070
Classification name
Orthosis, Spondylolisthesis Spinal Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
GORDON TAO
Address
25590 Seaboard Ln. Hayward CA US 94545 94545

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine2016-03-02
K143013Spinal Inner Fixation SystemChangzhou Dingjian Medical Appliance Co., Ltd.2015-12-11
K151695Romeo posterior osteosynthesis systemSpineart2015-09-10
K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine2015-06-26
K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC2015-04-29
K142798PASS LP Spinal SystemMedicrea International SA2015-03-25
K143417ANAX 5.5 Spinal SystemU&I Corporation2015-02-25
K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.2015-02-12