FDA.reportPublic FDA data

SpineSmith IN:C2 Spinal Fixation System

Primary DI
00817771029822
Brand
SpineSmith IN:C2 Spinal Fixation System
Company
Celling Biosciences
Model
1110-0002-PL
Catalog number
1110-0002-PL
Device description
IN:C2 Cervical System Kit w/stopless Trials - UDI not correct. Do Not Use
Published
2018-02-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122630000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122630000IN:C2 SPINAL FIXATION SYSTEMSpine Smith Partners L.P.2012-12-05OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817771029822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817771029822008177710298228177710298220817771029822

GMDN Terms#

Term, Definition table
TermDefinition
Metal-polymer composite spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of a non-bioabsorbable synthetic polymer with a metallic coating that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
512-206-0770CustomerService@CellingBiosciences.com

Regulatory Flags#

DUNS number
021560394
Device count
1
Kit
true
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
00817771027316SpineSmith Fusionary Graft Delivery System0851-00300851-00302016-12-29
00817771027323SpineSmith Fusionary Graft Delivery System0851-00610851-00612016-12-29
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
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
00810017913657Saber-C Body (PT), 12x15x6 6 deg.ELEVATION SPINE, INC.OVE2026-06-01
M711511410070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511410120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511411070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511411120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511412070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511412120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511606070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511607070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511607120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511608070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511608120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511609070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511609120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511610070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511610120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511611070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511611120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511612070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511612120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511806070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511807070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511807120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511808070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511808120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511809070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511809120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511810070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511810120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511811070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31