FDA.reportPublic FDA data

AXIS® Fixation System

Primary DI
00721902815522
Brand
AXIS® Fixation System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X8700214
Device description
AXIS SCR-TI-CANC-W/HOLE-3.5X14
Published
2015-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924085000RECONSTRUCTION PLATE SYSTEMSofamor Danek Mfg., Inc.1992-12-17HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00721902815522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00721902815522007219028155227219028155220721902815522

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
00763000992521INFINITY OCT SystemG36535102026-09-26
00763000992552INFINITY OCT SystemG36535162026-09-26
00643169016798Medtronic Reusable InstrumentsX06110012022-11-27
00643169016804Medtronic Reusable InstrumentsX06110022022-11-27
00673978816241Medtronic Reusable InstrumentsX06990402022-11-27
00613994423559N/AX07072142022-11-14
00613994423566N/AX07072152022-11-14
00613994423573N/AX07072162022-11-14
00613994423603N/AX07072192022-11-14
00643169588219Medtronic Resuable InstrumentsX08108352022-11-14
00643169860940Medtronic Resuable InstrumentsX07160322022-11-14
00643169860957Medtronic Resuable InstrumentsX07160332022-11-14
00613994107169Medtronic Reusable InstrumentsX08050732022-10-07
00613994230676Medtronic Reusable InstrumentsX07061412022-10-07
00613994404510Medtronic Reusable InstrumentsX07061942022-10-07
00613994507129Medtronic Reusable InstrumentsX08081362022-10-07
00613994507150Medtronic Reusable InstrumentsX08081392022-10-07
00613994507174Medtronic Reusable InstrumentsX08081412022-10-07
00613994838797Medtronic Reusable InstrumentsX06102712022-10-07
00613994838803Medtronic Reusable InstrumentsX06102702022-10-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00889095611274ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
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