FDA.reportPublic FDA data

InFill Lordotic ACF

Primary DI
00814729025516
Brand
InFill Lordotic ACF
Company
PINNACLE SPINE GROUP, LLC
Model
34-06-141208
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140066000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140066000INFILL CERVICALPinnacle Spine Group, LLC2014-05-05ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814729025516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814729025516008147290255168147290255160814729025516

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
"[""Radiation Sterilization"", ""Moist Heat or Steam Sterilization""]"
Radiation Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
962347980
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814729020009InFill V2 Lateral PEV2-00-183008-PE2016-08-26
00814729020016InFill V2 Lateral PEV2-00-183010-PE2016-08-26
00814729020023InFill V2 Lateral PEV2-00-183012-PE2016-08-26
00814729020030InFill V2 Lateral PEV2-00-183014-PE2016-08-26
00814729020047InFill V2 Lateral PEV2-07-183008-PE2016-08-26
00814729020054InFill V2 Lateral PEV2-07-183010-PE2016-08-26
00814729020061InFill V2 Lateral PEV2-07-183012-PE2016-08-26
00814729020078InFill V2 Lateral PEV2-07-183014-PE2016-08-26
00814729020085InFill V2 Lateral PEV2-10-183008-PE2016-08-26
00814729020092InFill V2 Lateral PEV2-10-183010-PE2016-08-26
00814729020108InFill V2 Lateral PEV2-10-183012-PE2016-08-26
00814729020115InFill V2 Lateral PEV2-10-183014-PE2016-08-26
00814729020122InFill V2 Lateral PEV2-13-183010-PE2016-08-26
00814729020139InFill V2 Lateral PEV2-13-183012-PE2016-08-26
00814729020146InFill V2 Lateral PEV2-13-183014-PE2016-08-26
00814729020153InFill V2 Lateral PEV2-00-183508-PE2016-08-26
00814729020160InFill V2 Lateral PEV2-00-183510-PE2016-08-26
00814729020177InFill V2 Lateral PEV2-00-183512-PE2016-08-26
00814729020184InFill V2 Lateral PEV2-00-183514-PE2016-08-26
00814729020191InFill V2 Lateral PEV2-07-183508-PE2016-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102289Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102296Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102302Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102319Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102326Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102333Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102340Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102357Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102364Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102371Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102388Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102395Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102401Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102418Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102425Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22