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
Primary DIBrandCompanyProduct codePublished
05391530753944FD-1017NS - 1ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951FD-1018NS - 1ml PC Syringe - Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217FD-1078NS 20ml PC Syringe - White Plunger - Saline PrintDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620FD-1048NS 10ml PC Syringe Yellow Plunger LidocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699FD-1075NS 10ml PC Syringe Light Blue Plunger XylocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941FD-1180NS 3ml Nugen Syringe Red PlungeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965FD-1162NS 10ml Nugen Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753609FD-1039NS - 10ml PC Syringe - Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678FD-1044NS - 10ml PC Syringe - Contrast Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01