FDA.reportPublic FDA data

NA

Primary DI
00889024492653
Brand
NA
Company
Orthosoft Inc
Model
20-8000-020-26
Published
2017-09-12
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
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032917000NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREEOrthosoft, Inc.2003-10-21HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024492653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024492653008890244926538890244926530889024492653

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. 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
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
00887868552120ROSA®20-8020-158-0020-8020-158-002023-04-10
00887868552137ROSA®20-8020-159-0020-8020-159-002023-04-10
00887868552144ROSA®20-8020-160-0020-8020-160-002023-04-10
00889024687455ROSA® Knee20-8020-130-012025-11-21
00887868581083ROSA® Robotics20-8020-013-0020-8020-013-002026-02-20
00889024703186ROSA® Shoulder20-8087-700-0020-8087-700-002026-01-27
00889024674790ROSA PIN STABILIZER 60MM20-8020-039-0020-8020-039-002025-12-12
00889024674776ROSA POLYAXIAL REFERENCE SIZE 320-8020-037-0020-8020-037-002025-12-11
00889024674783ROSA POLYAXIAL REFERENCE SIZE 620-8020-038-0020-8020-038-002025-12-11
00889024674806ROSA STABILIZER TISSUE DEFLECTOR 60MM20-8020-040-0020-8020-040-002025-12-11
00887868557873ROSA® Shoulder20-8087-100-01208087100012024-03-06
00887868557880ROSA® Shoulder20-8087-100-02208087100022024-03-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07340201503843Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
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