FDA.reportPublic FDA data

IO-FLEX

Primary DI
00840916103873
Brand
IO-FLEX
Company
SPINAL ELEMENTS
Model
iO-Tome10
Device description
IO-Flex Microblade Shaver IO-Tome Device 10mm
Published
2017-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113073000IO-TOME DEVICEBaxano, Inc.2012-07-27HAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916103873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916103873008409161038738409161038730840916103873

GMDN Terms#

Term, Definition table
TermDefinition
Spinal curetteA hand-held, sterile surgical instrument used to scrape and score the cancellous vertebral bone of the spine, typically during a percutanous, minimally-invasive procedure. It consists of a long, thin, metal shaft that terminates distally in a mushroom-like cutting head that can be set at alternative angles (up to ninety degrees). The device enables a smooth scoring action for the creation of grooves or channels, and is typically used as an adjunct device in the treatment of vertebral compression fractures (VCFs) during kyphoplasty. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004022104
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840916162115DIAMOND100402022-03-03
00840916162122DIAMOND100432022-03-03
00840916162139DIAMOND100472022-03-03
00840916142926ZEUS-O101122021-01-11
00840916143008ZEUS-O109972021-01-11
00840916160135SPARTAN103132020-12-07
00840916156947ZEUS-O105002020-05-11
00840916117603SLPSS82192017-08-10
00840916149840SAVANNAH91052020-04-16
00840916150143SAVANNAH82712020-04-16
00840916150150SAVANNAH90012020-04-16
00840916150167SAVANNAH90022020-04-16
00840916150174SAVANNAH90042020-04-16
00840916150211SAVANNAH90502020-04-16
00840916150228SAVANNAH90902020-04-16
00840916115555SAMSON135142017-08-01
00840916115562SAMSON135152017-08-01
00840916115579SAMSON135162017-08-01
00840916115586SAMSON135172017-08-01
00840916115593SAMSON135182017-08-01

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00850003512129SteribiteSteribite, LLCHAE2026-08-27
00850003512167SteribiteSteribite, LLCHAE2026-08-27
00850003512235SteribiteSteribite, LLCHAE2026-08-27
00850003512273SteribiteSteribite, LLCHAE2026-08-27
00850003512310SteribiteSteribite, LLCHAE2026-08-27
00850003512358SteribiteSteribite, LLCHAE2026-08-27
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