FDA.reportPublic FDA data

Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical System

Primary DI
00815351021877
Brand
Anterior Cervical Stabilization System (SSACSS), Kwik-Fix/TS® Cervical System
Company
Southern Spine LLC
Model
38010
Device description
Drill Bit, Offset Assembly
Published
2016-08-04
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
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021979000
K063764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021979000SMISSON STABILIZATION SYSTEMSmisson-Cartledge2003-06-27KWQ
K063764000SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEMSouthern Spine, LLC2007-05-16KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815351021877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815351021877008153510218778153510218770815351021877

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. 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

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