FDA.reportPublic FDA data

InSpan®

Primary DI
00190361039556
Brand
InSpan®
Company
SPINEFRONTIER, INC.
Model
11-60082-12
Device description
12mm InSpan Sizing Trial
Published
2016-10-05
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
K102020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102020000VEGA SPAN SPINOUS PROCESS PLATE SYSTEMSpinefrontier, Inc.2010-09-01KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190361039556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190361039556001903610395561903610395560190361039556

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(866)914-7717customerservice@spinefrontier.com

Regulatory Flags#

DUNS number
002003243
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190361000983Indus®01-71002-172016-04-15
00190361000990Indus®01-71002-192016-04-15
00190361001003Indus®01-71002-212016-04-15
00190361001010Indus®01-71002-232016-04-15
00190361001027Indus®01-71002-252016-04-15
00190361001034Indus®01-71002-272016-04-15
00190361001041Indus®01-71002-292016-04-15
00190361001058Indus®01-71002-312016-04-15
00190361001065Indus®01-71002-332016-04-15
00190361001072Indus®01-71002-352016-04-15
00190361001089Indus®01-710032016-04-15
00190361001096Indus®01-71004-332016-04-15
00190361001102Indus®01-71004-352016-04-15
00190361001119Indus®01-71004-372016-04-15
00190361001126Indus®01-71004-392016-04-15
00190361001133Indus®01-71004-412016-04-15
00190361001140Indus®01-71004-432016-04-15
00190361001157Indus®01-71004-452016-04-15
00190361001164Indus®01-71004-472016-04-15
00190361001171Indus®01-71004-492016-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606186544OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
00840606186551OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
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10888857598171Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
00613994738646ZEPHIR® Anterior Cervical SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2019-03-07
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
04546540147257XIA IIStryker CorporationKWP2014-12-08
04546540147769XIA IIStryker CorporationKWP2014-12-08
04546540147806XIA IIStryker CorporationKWP2014-12-08
04546540147905XIA IIStryker CorporationKWP2014-12-08
04546540147912XIA IStryker CorporationKWP2014-12-08
04546540147929XIA IStryker CorporationKWP2014-12-08
04546540147936XIA IStryker CorporationKWP2014-12-08
04546540147974XIA IStryker CorporationKWP2014-12-08
04546540147981XIA IStryker CorporationKWP2014-12-08
04546540147998XIA IStryker CorporationKWP2014-12-08
04546540148001XIA IIStryker CorporationKWP2014-12-08
04546540148018XIA IIStryker CorporationKWP2014-12-08
04546540148025XIA IIStryker CorporationKWP2014-12-08