AnyPlus Spinal Fixation System 0983-5550-A0

GUDID 08806162131987

The AnyPlus Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to create a rigid spinal construct. The components are manufactured from Ti6AI4V ELI according to ISO 5832-3 and ASTM F-136. The rods are also manufactured from Cobalt Chromium according to F1537-11. The screws are available from 4.0 to 10.5mm diameters with lengths ranging from 20 to 100mm (Length does not include the screw head). Specialized instruments are available for the application and removal of the Anypluss Spinal Fixation System. AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1 -S2), a posterior hook fixation system (T 1-5), or as a anterolateral fixation system (T8-L_5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

GS Medical Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID08806162131987
NIH Device Record Key07e50270-f89d-426a-8f70-1be9ee95ef8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnyPlus Spinal Fixation System
Version Model Number0983-5550-A0
Catalog Number0983-5550-A0
Company DUNS688385418
Company NameGS Medical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108806162131987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[08806162131987]

Moist Heat or Steam Sterilization

[08806162131987]

Moist Heat or Steam Sterilization

[08806162131987]

Moist Heat or Steam Sterilization

[08806162131987]

Moist Heat or Steam Sterilization

[08806162131987]

Moist Heat or Steam Sterilization

[08806162131987]

Moist Heat or Steam Sterilization

[08806162131987]

Moist Heat or Steam Sterilization

[08806162131987]

Moist Heat or Steam Sterilization

[08806162131987]

Moist Heat or Steam Sterilization

[08806162131987]

Moist Heat or Steam Sterilization

[08806162131987]

Moist Heat or Steam Sterilization

[08806162131987]

Moist Heat or Steam Sterilization

[08806162131987]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-22
Device Publish Date2021-09-14

On-Brand Devices [AnyPlus Spinal Fixation System]

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