FDA.reportPublic FDA data

S-LIFT®

Primary DI
00190361038245
Brand
S-LIFT®
Company
SPINEFRONTIER, INC.
Model
11-50251-08
Device description
TRIAL, STRAIGHT, 19MM WIDE, 8MM
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
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111553000SPINEFRONTIER LUMBAR IBF SYSTEMSpinefrontier, Inc.2011-09-28MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190361038245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190361038245001903610382451903610382450190361038245

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the 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
08800043913099N/ATDM Co., Ltd.MAX2026-06-10
08800043913105N/ATDM Co., Ltd.MAX2026-06-10
08800043913112N/ATDM Co., Ltd.MAX2026-06-10
08800043913129N/ATDM Co., Ltd.MAX2026-06-10
08800043913136N/ATDM Co., Ltd.MAX2026-06-10
08800043913143N/ATDM Co., Ltd.MAX2026-06-10
08800043913150N/ATDM Co., Ltd.MAX2026-06-10
08800043913167N/ATDM Co., Ltd.MAX2026-06-10
08800043913174N/ATDM Co., Ltd.MAX2026-06-10
08800043913181N/ATDM Co., Ltd.MAX2026-06-10
08800043913198N/ATDM Co., Ltd.MAX2026-06-10
08800043913204N/ATDM Co., Ltd.MAX2026-06-10
08800043913211N/ATDM Co., Ltd.MAX2026-06-10
08800043917288N/ATDM Co., Ltd.MAX2026-06-10
08800043917295N/ATDM Co., Ltd.MAX2026-06-10
08800043917301N/ATDM Co., Ltd.MAX2026-06-10
08800043917318N/ATDM Co., Ltd.MAX2026-06-10
08800043917325N/ATDM Co., Ltd.MAX2026-06-10
08800043917332N/ATDM Co., Ltd.MAX2026-06-10
08800043917349N/ATDM Co., Ltd.MAX2026-06-10
08800043967177N/ATDM Co., Ltd.MAX2026-06-10
08800043967184N/ATDM Co., Ltd.MAX2026-06-10
08800043967191N/ATDM Co., Ltd.MAX2026-06-10
08800043967207N/ATDM Co., Ltd.MAX2026-06-10
08800043967214N/ATDM Co., Ltd.MAX2026-06-10
08800043967221N/ATDM Co., Ltd.MAX2026-06-10
08800043967238N/ATDM Co., Ltd.MAX2026-06-10
08800043967245N/ATDM Co., Ltd.MAX2026-06-10
08800043967252N/ATDM Co., Ltd.MAX2026-06-10
08800043967269N/ATDM Co., Ltd.MAX2026-06-10