FDA.report

Medtronic Reusable Instruments

Primary DI
00763000986285
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X07318008
Device description
HOLDER X07318008 SHIM IMPACTOR
Published
2025-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWAIMPACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000986285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000986285007630009862857630009862850763000986285

GMDN Terms

TermDefinition
Spinal intraoperative positioning pin, single-useA nonimplantable thin rod intended to be temporarily introduced, with a dedicated inserter (not included), into vertebral bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, distractor/retractor) during spinal surgery. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
830350380
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00199150015429CD HORIZON® Spinal System593290202026-03-21
00199150015436CD HORIZON® Spinal System593290212026-03-21
00199150024469INFINITY™ Occipitocervical Upper Thoracic SystemNAV36500052026-03-22
00199150024483INFINITY™ Occipitocervical Upper Thoracic SystemNAV36062002026-03-22
00199150038138INFINITY™ Occipitocervical Upper Thoracic SystemNAV36500302026-03-21
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00199150069675Medtronic Reusable InstrumentsX01260012026-03-20
00763000710194Medtronic Reusable Instruments and Accessories65520282026-03-22
00763000869069CD HORIZON® Spinal System593290142026-03-21
00763000869076CD HORIZON® Spinal System593290152026-03-21
00763000869090CD HORIZON® Spinal System593290172026-03-21
00763000869106CD HORIZON® Spinal System593290182026-03-21

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