FDA.reportPublic FDA data

N/A

Primary DI
00643169405257
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0613998
Device description
DISTRACTOR/TRIAL X0613998 9DEG 10X10X22
Published
2016-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K133650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133650000CAPSTONE SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.2013-12-20MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169405257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169405257006431694052576431694052570643169405257

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00673978130385GDLH® Posterior Spinal SystemX0196-1122015-08-23
00673978130392GDLH® Posterior Spinal SystemX0196-1142015-08-24
00673978130408GDLH® Posterior Spinal SystemX0196-1162015-08-24
00673978130415GDLH® Posterior Spinal SystemX0196-1182015-08-24
00673978130422GDLH® Posterior Spinal SystemX0196-1202015-08-24
00763000992316INFINITY™ Occipitocervical Upper Thoracic SystemG365PT35262026-07-24
00763000992323INFINITY™ Occipitocervical Upper Thoracic SystemG365PT35282026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166521604X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521611X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521765X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166523028X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
04251631420095NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420101NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420118NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420125NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420132NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420149NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420156NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420163NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420170NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420187NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420194NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421153BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421177BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421184BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421207BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421214BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421221BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421252BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421269BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421276BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421283BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421306BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421313BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421320BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421337BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421351BEE PLIF CageNGMedical GmbHMAX2026-07-30