FDA.reportPublic FDA data

INVISx®

Primary DI
00643169498006
Brand
INVISx®
Company
MEDTRONIC PS MEDICAL, INC.
Model
60710
Device description
INSTR 60710 INVISX TENSIONING REUSE
Published
2015-06-24
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
GXNPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010361000MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900Medtronic PS Medical2001-05-07GXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169498006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169498006006431694980066431694980060643169498006

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. 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
089055867
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000029449N/A8023 B2020-03-07
00763000030827N/A250772020-03-08
00643169483316NA8023 B2015-06-24
00643169498365NA250772015-07-14
00643169507517NA8023 A2015-06-25
00643169073623NA250772015-06-25
00643169466142N/A461412015-07-15
00673978228969NA464222015-06-18
00673978246017NA272972015-07-21
00673978246031NA273022015-07-14
20643169466122N/A464402015-07-15
00763000422646StrataMR246955MR2026-03-13
00763000422684StrataMR246957MR2026-03-13
00673978226835NA8591-602015-11-25
00643169497955Clear-Site®469182015-09-16
00613994450661Clear-Site®469182015-07-16
00763000422660StrataMR II46956MR2025-05-02
00763000422653Valve, StrataMR II, Regular46965MR2025-01-23
00763000422677Snap Shunt Assembly, StrataMR II, Regular46966MR2025-01-23
00763000422691Unassembled Shunt Kit, StrataMR II, Regular46967MR2025-01-23

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Primary DI, Brand, Company table
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00810188324665HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-01
00810188324641HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
00810188324658HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
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00810007631271AccuShapeMedcadGXN2023-06-23
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00810007631295AccuShapeMedcadGXN2023-06-23
00810077248829HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-16
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00810077248973HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-09
00810077248775HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-03
00810077248706HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248850HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248904HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248911HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21