FDA.report

MEGA PLUS SPINE SYSTEM

Primary DI
08809763501210
Brand
MEGA PLUS SPINE SYSTEM
Company
BK MEDITECH CO.,LTD.
Model
10150
Device description
Multi-Axial Screw Driver
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HXXScrewdriver

Product Code Classifications

CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809763501210PrimaryGS10

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
687941818
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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08809155852326MEGA PLUS SPINE SYSTEM61120-0452018-03-23
08809155852333MEGA PLUS SPINE SYSTEM61120-222018-03-23
08809155852340MEGA PLUS SPINE SYSTEM61120-242018-03-23
08809155852357MEGA PLUS SPINE SYSTEM61120-262018-03-23
08809155852364MEGA PLUS SPINE SYSTEM61120-282018-03-23
08809155857109MEGA PLUS SPINE SYSTEM61120-142018-03-23
08809155857116MEGA PLUS SPINE SYSTEM61120-152018-03-23
08809155857130MEGA PLUS SPINE SYSTEM61120-172018-03-23
08809155857147MEGA PLUS SPINE SYSTEM61120-182018-03-23
08809155857154MEGA PLUS SPINE SYSTEM61120-192018-03-23
08809155857178MEGA PLUS SPINE SYSTEM61120-252018-03-23
08809155857185MEGA PLUS SPINE SYSTEM61120-302018-03-23

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