FDA.reportPublic FDA data

StabiLink®MIS Spinal Fixation System

Primary DI
00815351020719
Brand
StabiLink®MIS Spinal Fixation System
Company
Southern Spine LLC
Model
BT-16
Device description
Base, Tray Device, 16mm
Published
2015-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123093000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123093000STABILINK MIS SPINAL FIXATION SYSTEMSouthern Spine, LLC2012-12-20KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815351020719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815351020719008153510207198153510207190815351020719

GMDN Terms#

Term, Definition table
TermDefinition
Interspinous spinal fixation implantAn implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(478)330-6205donna@t3med.com

Regulatory Flags#

DUNS number
794672225
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815351022683Deploy™ Expandable Interbody SystemDT-12442022-01-10
00815351020009Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System10212015-10-16
00815351020016Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System10242015-10-16
00815351020023Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System10272015-10-16
00815351020030Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System10302015-10-16
00815351020047Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System10332015-10-16
00815351020054Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System20362015-10-16
00815351020061Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System20392015-10-16
00815351020078Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System20422015-10-16
00815351020085Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System20452015-10-16
00815351020092Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System20482015-10-16
00815351020108Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System30542015-10-16
00815351020115Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System30582015-10-16
00815351020122Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System30622015-10-16
00815351020139Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System30662015-10-16
00815351020146Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System30702015-10-16
00815351020153Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System40722015-10-16
00815351020160Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System40762015-10-16
00815351020177Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System40802015-10-16
00815351020184Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System40842015-10-16

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Primary DI, Brand, Company table
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