FDA.report

TIGER SHARK SYSTEM

Primary DI
00840996188944
Brand
TIGER SHARK SYSTEM
Company
Choice Spine, LP
Model
S-PT50-A3203
Device description
TIGERSHARK M,STERILE,SPACER,32LX3H
Published
2023-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840996188944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840996188944008409961889448409961889440840996188944

GMDN Terms

TermDefinition
Intervertebral-body internal spinal fixation systemA group of sterile implantable devices designed to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The system components are typically made of medical grade titanium and consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the centre of each plate, and a braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and is fastened or crimped at each eye-type screw.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
+1(865)246-3333info@choicespine.net

Regulatory Flags

DUNS number
078293017
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00840996150781Acapella One05-099-05-16072024-02-24
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00840283403194LumiVy™VY SPINE LLCMAX2026-03-24
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