FDA.reportPublic FDA data

A-CIFT

Primary DI
00190361027911
Brand
A-CIFT
Company
SPINEFRONTIER, INC.
Model
14-32121-0611
Device description
A-CIFT TRIAL HEADS, 14x 19, 6°, 11MM
Published
2020-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVEIntervertebral fusion device with integrated fixation, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131880000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131880000SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEMSpinefrontier, Inc.2014-01-03OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190361027911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190361027911001903610279111903610279110190361027911

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle6degree
Height11Millimeter
Length13.5Millimeter
Width19Millimeter

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
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
08800322776391QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776407QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776414QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776421QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776438QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776445QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776452QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776469QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776476QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776483QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776490QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776506QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776513QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776520QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776537QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776544QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776551QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776568QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776575QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776582QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776599QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776605QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776612QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776629QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776636QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776643QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776650QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776667QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776674QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776681QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18