FDA.reportPublic FDA data

X-STOP® Interspinous Spacer

Primary DI
00643169117556
Brand
X-STOP® Interspinous Spacer
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
4-3500
Device description
TRAY 4-3500 US X STOP PK INSTRUMENT SET
Published
2014-09-23
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
NQOProsthesis, spinous process spacer/plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQOProsthesis, Spinous Process Spacer/PlateUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040001020

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040001020X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEMMedtronic Sofamor Danek, Inc.2005-11-21NQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169117556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169117556006431691175566431691175560643169117556

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

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
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24
00199150071814Medtronic Reusable InstrumentsEX02261002026-05-24
00199150072057Medtronic Reusable InstrumentsX65500232026-05-23
00199150072064Medtronic Reusable InstrumentsX65500242026-05-23
00199150072576Medtronic Reusable InstrumentsEX02260222026-05-23
00199150074532Medtronic Reusable InstrumentsX12250022026-05-22
00199150074549Medtronic Reusable InstrumentsX12250032026-05-22

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Primary DI, Brand, Company table
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03701521300378DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
03701521300385DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
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00884662000529Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2020-09-28
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00884662000567Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
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04260148897771coflex trial with guide and x-ray marker, 14mmParadigm Spine GmbHNQO2018-06-28
04260148897788coflex trial with guide and x-ray marker, 16mmParadigm Spine GmbHNQO2018-06-28
04260148897795coflex trial slider with wingsParadigm Spine GmbHNQO2018-06-28
04260148897801coflex trial capParadigm Spine GmbHNQO2018-06-28
04260148897832coflex wing loosenerParadigm Spine GmbHNQO2018-06-28
04260148898594coflex freehand crimping pliersParadigm Spine GmbHNQO2018-06-28
04260148898600coflex extractor pliersParadigm Spine GmbHNQO2018-06-28
04260148898358coflex single-use instrumentsParadigm Spine GmbHNQO2018-06-14
00884662000574Superion™ SUIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2018-04-05
00884662000611Vertiflex™ VIPBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2018-04-05
00884662000123Superion DriverVERTIFLEX, INC.NQO2017-08-16