FDA.reportPublic FDA data

StabiLink®MIS Spinal Fixation System

Primary DI
00815351021495
Brand
StabiLink®MIS Spinal Fixation System
Company
Southern Spine LLC
Model
PS-300
Device description
Plate Selector
Published
2016-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00815351021495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815351021495008153510214958153510214950815351021495

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
00199150015832INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015849INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015856INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015863INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015870INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015887INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015894INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015900INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015917INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015924INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015931INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015948INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015955INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015962INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015986INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016006INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016013INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016037INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016044INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016051INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016068INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016075INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016082INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016099INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-28
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-27
10889981441555VIRATASeaspine Orthopedics CorporationKWP2026-06-24