FDA.reportPublic FDA data

CRESCENT™ Spinal System

Primary DI
00643169666047
Brand
CRESCENT™ Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0415017
Device description
SPACER X0415017 CRESCENT PK 40X14
Published
2017-11-13
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
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171031000CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017-07-06MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169666047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169666047006431696660476431696660470643169666047

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
Height14Millimeter
Length40Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150076468Medtronic Reusable InstrumentsX46810082026-08-03
00199150076475Medtronic Reusable InstrumentsX46820082026-08-03
00199150076482Medtronic Reusable InstrumentsX46800202026-08-03
00199150076499Medtronic Reusable InstrumentsX46800212026-08-03
00199150083473Medtronic Reusable InstrumentsEX75709002026-08-03
00763000858063T2 STRATOSPHERE™ Expandable Corpectomy System4361254002026-08-01
00763000992026MSB CD HORIZON Spinal SystemX04150662026-08-02
00199150081073Medtronic Reusable InstrumentsX04260042026-07-30
00199150081905Medtronic Reusable InstrumentsX04260022026-07-30
00199150083107Medtronic Reusable InstrumentsEX10040072026-07-30
00199150083879Medtronic Reusable InstrumentsX09074112026-07-30
00763000887216MSB CD HORIZON Spinal System65435352026-07-30
00721902975158GDLH® Posterior Spinal SystemX0196-1112015-08-05
00721902975189GDLH® Posterior Spinal SystemX0196-1222015-08-05
00721902975219GDLH® Posterior Spinal SystemX0196-1262015-08-05
00721902975226GDLH® Posterior Spinal SystemX0196-1282015-08-05
00721902975233GDLH® Posterior Spinal SystemX0196-1302015-08-05
00673978130316GDLH® Posterior Spinal SystemX0196-1042015-08-24
00673978130347GDLH® Posterior Spinal SystemX0196-1072015-08-24
00673978130361GDLH® Posterior Spinal SystemX0196-1092015-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00843511102593Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
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00843511102692Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102708Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
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00843511102722Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102739Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102746Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102753Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102760Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102777Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102784Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102791Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102807Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102814Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102821Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102838Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102845Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
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00810166521611X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521765X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30