Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology

Primary DI
00763000357559
Brand
Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
2968001
Device description
TRAY 2968001 TLIF-DLIF NAV INSERTER SET
Published
2020-11-06
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
KTPCOMPLEMENT C3B ACTIVATOR IMMUNOASSAY REAGENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTPComplement C3b Activator Immunoassay ReagentsImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190840000Medtronic Transportation / Sterilization CassettesMedtronic Sofamor Danek USA, Inc.2019-10-15KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000357559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000357559007630003575597630003575590763000357559

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. 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
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169236967n/a74806532026-10-11
00643169236974n/a74806522026-10-11
00643169236981n/a74806512026-10-11
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy System43612582026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy System43612252026-10-11
00763000874209MSB SHILLA Growth Guidance System76745002026-10-11
00763000885502MSB Reusable Instruments7080921D2026-10-11
00824846010722Medtronic Reusable InstrumentsX07260022026-10-09
00643169964938GRAFTON™ DBMT42275INT2024-12-05
00643169965102GRAFTON PLUS™ DBMT45005INT2024-11-15
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUS0005052021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUS0050012021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUS0050052021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUS0051102021-03-12
00763000140540PROGENIX™ PUTTY and PROGENIX™ PLUS0060012021-03-12
00763000140557PROGENIX™ PUTTY and PROGENIX™ PLUS0060022021-03-12
00763000140564PROGENIX™ PUTTY and PROGENIX™ PLUS0060052021-03-12
00763000140571PROGENIX™ PUTTY and PROGENIX™ PLUS0060102021-03-12
00643169965089GRAFTON® DBMT44150INT2019-02-07
00613994247612PROGENIX® PUTTY and PROGENIX® PLUS0051102019-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000357535Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMEDTRONIC SOFAMOR DANEK, INC.KTP2020-11-06