FDA.reportPublic FDA data

InFill Graft Delivery System

Primary DI
00814729026155
Brand
InFill Graft Delivery System
Company
PINNACLE SPINE GROUP, LLC
Model
99-0500
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143488000InFill Graft Delivery SystemPinnacle Spine Group, LLC2014-12-17FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814729026155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814729026155008147290261558147290261550814729026155

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantable material dispenser, reservoir-containingA non-powered, syringe-/pipette-like device intended to load orthopaedic cement and/or a bone void filling material (not included) within an included reservoir/barrel and dispense the material during surgery. It is not designed to accept a separate cartridge/syringe or prepare/mix the substance. It may be intended to be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization
Radiation Sterilization

Regulatory Flags#

DUNS number
962347980
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814729026162InFill Graft Delivery System (Modified)99-05202016-08-26
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934841531291TKMDAnhui Tiankang Medical Technology Co., Ltd.FMF2026-10-23
MHC182332552EasyTouchMHC MEDICAL PRODUCTS, LLCFMF2026-10-21
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193867Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193874Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193898Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194109Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194116Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194208Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194215Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194222Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
00850091070532CoreCareCorecare Products Inc.FMF2026-09-11
00850091070556CoreCareCorecare Products Inc.FMF2026-09-11
00850091070570CoreCareCorecare Products Inc.FMF2026-09-11
00850091070594CoreCareCorecare Products Inc.FMF2026-09-11
00850091070617CoreCareCorecare Products Inc.FMF2026-09-11
00850091070631CoreCareCorecare Products Inc.FMF2026-09-11
00850091070655CoreCareCorecare Products Inc.FMF2026-09-11
00850091070679CoreCareCorecare Products Inc.FMF2026-09-11
10816336022671NC603500-ENFNEOCHILD, LLCFMF2026-09-10
00850091070242CoreCareCorecare Products Inc.FMF2026-09-04