FDA.reportPublic FDA data

InTice™ -C Porous Ti Cervical Interbody System

Primary DI
M697X0980612STR1
Brand
InTice™ -C Porous Ti Cervical Interbody System
Company
Xtant Medical Holdings, Inc.
Model
X098-0612-STR
Device description
InTice™-C 15mm x 18mm x 12mm Parallel-Convex
Published
2019-11-18
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173832000InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.2018-05-17ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X0980612STR1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic 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 metal [e.g., titanium (Ti)] 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height12Millimeter
Length15Millimeter
Width18Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(888)886-9354CS@xtantmedical.com
+1(888)886-9354CS@xtantmedical.com

Regulatory Flags#

DUNS number
081224143
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00840311258185Fusion Lateral Instrument Set38-SLAPHAMMER2026-10-23
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemX064-02402026-10-14
M697X07300151Xpress Minimally Invasive Pedicle Screw SystemX073-00152026-10-14
M697X07300251Xpress Minimally Invasive Pedicle Screw SystemX073-00252026-10-14
M697X07300261Xpress Minimally Invasive Pedicle Screw SystemX073-00262026-10-14
M697X07300271Xpress Minimally Invasive Pedicle Screw SystemX073-00272026-10-14
M697X07300291Xpress Minimally Invasive Pedicle Screw SystemX073-00292026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemX073-825100-DL2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82560-DL2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82565-DL2026-10-14
M697X07382570DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82570-DL2026-10-14
M697X07382575DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82575-DL2026-10-14
M697X07382580DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82580-DL2026-10-14
M697X07382585DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82585-DL2026-10-14
M697X07382590DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82590-DL2026-10-14
M697X07382595DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82595-DL2026-10-14
00849777014144Vesuvius Flowable DBM, 1cc4104-K5010DP2026-09-14
00849777014151Vesuvius Flowable DBM, 2.5cc4104-K5025DP2026-09-14
00849777014168Vesuvius Flowable DBM, 5cc4104-K5050DP2026-09-14
00849777014175Vesuvius Flowable DBM, 10cc4104-K5100DP2026-09-14

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Primary DI, Brand, Company table
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00810017913978Saber-C Body (PT), 14x17x8 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913985Saber-C Body (PT), 14x17x9 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
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00810017914005Saber-C Body (PT), 15x18x5 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914012Saber-C Body (PT), 15x18x6 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914029Saber-C Body (PT), 15x18x7 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
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B084AC1141605070Anterior Cervical IBFDKEOSODP2024-02-09
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