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
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 cement dispenserA syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may 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
"[""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
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00850091070402CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070419CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
06976523540238Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540252Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
00193982458126INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
00193982504403INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
00884450487402Merit Medical®Merit Medical Systems, Inc.FMF2026-08-07
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
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10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
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