FDA.reportPublic FDA data

SpineSmith Fusionary Graft Delivery System

Primary DI
00817771027323
Brand
SpineSmith Fusionary Graft Delivery System
Company
Celling Biosciences
Model
0851-0061
Catalog number
0851-0061
Device description
BMA Kit Standard
Published
2016-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
LWEBone Marrow Collection/Transfusion Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
LWEBone Marrow Collection/Transfusion KitUnknown2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0900470

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0900470

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817771027323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817771027323008177710273238177710273230817771027323

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft syringeA sterile and calibrated hollow barrel (cylinder) containing a plunger, designed to prepare and deliver bone graft materials (e.g., autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic/composite bone matrix graft materials) during an orthopaedic surgical procedure. With the use of a dedicated needle, it allows for the aspiration and mixing of the materials and their delivery to the surgical site. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
512-637-6745CustomerService@CellingBiosciences.com

Regulatory Flags#

DUNS number
021560394
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817771027316SpineSmith Fusionary Graft Delivery System0851-00300851-00302016-12-29
00817771027354SpineSmith Fusionary Graft Delivery System0851-10600851-10602016-12-28
00817771027361SpineSmith Fusionary Graft Delivery System0851-10700851-10702016-12-28
00817771027378SpineSmith Fusionary Graft Delivery System0851-30600851-30602016-12-29
00817771027385SpineSmith Fusionary Graft Delivery System0852-00010852-00012016-12-29
00817771027392SpineSmith Fusionary Graft Delivery System0852-01200852-01202016-12-29
00817771029761Solum FlowSolum Flow - 10cc1206-01002025-08-05
00817771027637SpineSmith IN:C2 Spinal Fixation System1100-0002-PL1100-0002-PL2018-02-14
00817771029815SpineSmith IN:C2 Spinal Fixation System1110-0001-PL1110-0001-PL2018-02-14
00817771029822SpineSmith IN:C2 Spinal Fixation System1110-0002-PL1110-0002-PL2018-02-14
00817771027439ART BMC System Centrifuge0882-00010882-00012025-04-11
00817771027460ART BMC System Centrifuge0882-00040882-00042025-04-11
00817771027484ART BMC System Centrifuge0882-00200882-00202025-04-11
00817771028788Celling ART BMC Plus 0866-00020866-00022025-04-11
00817771028795Celling ART BMC 0886-00010886-00012025-04-11
00817771028825Celling ART PRP 2-Step 60 Kit1651-00041651-00042025-04-11
00817771028849Celling Cardio Application Kit0851-00030851-00032025-04-11
00817771028856Celling ART PRP 2-Step 120 Kit1651-00051651-00052025-04-11
00817771028870Celling ART PRP 2-Step Mini Kit1651-00021651-00022025-04-11
00817771029174Celling ART PRP 2-Step1601-00011601-00012025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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