FDA.reportPublic FDA data

NA

Primary DI
00889024305410
Brand
NA
Company
Orthosoft Inc
Model
20-8011-042-00
Catalog number
20-8011-042-00
Published
2016-09-07
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
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122326000SMARTTOOLS KNEE SYSTEMZimmer2012-11-30OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024305410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024305410008890243054108890243054100889024305410

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guideA non-sterile surgical instrument intended to be attached to a portion of bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure to outline the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(800)-348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
205670032
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024673403NavitrackER®20-8087-000-0020-8087-000-002026-06-26
00889024707047Signature ONE Software Package302.4018302.40182026-07-10
00889024699762ROSA® Shoulder20-8087-142-0020-8087-142-002026-06-26
00889024699779ROSA® Shoulder20-8087-141-0020-8087-141-002026-06-26
00889024699786ROSA® Shoulder20-8087-150-0120-8087-150-012026-06-26
00889024699793ROSA® Shoulder20-8087-151-0020-8087-151-002026-06-26
00889024699809ROSA® Shoulder20-8087-150-0220-8087-150-022026-06-26
00889024699816ROSA® Shoulder20-8087-150-0320-8087-150-032026-06-26
00889024699823ROSA® Shoulder20-8087-140-0020-8087-140-002026-06-26
00887868558467iASSIST® Knee System302.4021302.40212022-09-21
00887868558474iASSIST® Knee System20-8011-900-1320-8011-900-132022-09-21
00889024211605NA302.4002302.40022016-09-14
00889024211636iASSIST302.4001302.40012016-09-14
00889024305083Sesamoid20-8000-070-3520-8000-070-352016-09-12
00889024305090Sesamoid20-8000-070-3620-8000-070-362016-09-12
00889024305106Sesamoid20-8000-070-3720-8000-070-372016-09-12
00889024305113Sesamoid20-8000-070-3820-8000-070-382016-09-12
00889024305120Sesamoid20-8000-070-3920-8000-070-392016-09-12
00889024305205Sesamoid20-8000-070-6420-8000-070-642016-09-12
00889024478954Sesamoid Plasty V2 Stand20-8000-070-8020-8000-070-802016-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810076335322MomentumUlrich Medical Usa, Inc.OLO2026-09-25
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOLO2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOLO2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
07613327460667Navigation EnabledStryker CorporationOLO2019-10-16
07613327460674Navigation EnabledStryker CorporationOLO2019-10-16
07613327460681Navigation EnabledStryker CorporationOLO2019-10-16
07613327460698Navigation EnabledStryker CorporationOLO2019-10-16
07613327460704Navigation EnabledStryker CorporationOLO2019-10-16
07613327460711Navigation EnabledStryker CorporationOLO2019-10-16
07613327460728Navigation EnabledStryker CorporationOLO2019-10-16
07613327460735Navigation EnabledStryker CorporationOLO2019-10-16
07613327460742Navigation EnabledStryker CorporationOLO2019-10-16
07613327460759Navigation EnabledStryker CorporationOLO2019-10-16
07613327460766Navigation EnabledStryker CorporationOLO2019-10-16
07613327460773Navigation EnabledStryker CorporationOLO2019-10-16
07613327460780Navigation EnabledStryker CorporationOLO2019-10-16
07613327460797Navigation EnabledStryker CorporationOLO2019-10-16
07613327460810Navigation EnabledStryker CorporationOLO2019-10-16
07613327460827Navigation EnabledStryker CorporationOLO2019-10-16
07613327460834Navigation EnabledStryker CorporationOLO2019-10-16
07613327460841Navigation EnabledStryker CorporationOLO2019-10-16
07613327460858Navigation EnabledStryker CorporationOLO2019-10-16
07613327460865Navigation EnabledStryker CorporationOLO2019-10-16
07613327460872Navigation EnabledStryker CorporationOLO2019-10-16
07613327460889Navigation EnabledStryker CorporationOLO2019-10-16
07613327460896Navigation EnabledStryker CorporationOLO2019-10-16