FDA.report

NA

Primary DI
07613154681884
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
6007-613-001
Catalog number
6007-613-001
Device description
UNIVERSAL HIP NAVIGATION S
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HAWNeurological stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613154681884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613154681884076131546818847613154681884

GMDN Terms

TermDefinition
Robotic surgical navigation system application softwareAn individual application software program or group of programs, routines and/or algorithms designed for use in association with a robotic surgical navigation system used in computer assisted surgery (CAS) so that this can function according to its intended purpose. This program can be permanently installed or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods

Method

Regulatory Flags

DUNS number
316153956
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07613327682717NA92-0232592-023252026-02-27
07613327682724NA92-0232492-023242026-02-27
37613327090810NA92-1710592-171052015-09-24
37613327090827NA92-1710492-171042015-09-24
37613327090834NA92-1710692-171062015-09-24
37613327090841NA92-1710892-171082015-09-24
37613327090858NA92-8170392-817032015-09-24
37613327090865NA92-8170492-817042015-09-24
37613327090872NA92-8170592-817052015-09-24
37613327090889NA92-8170692-817062015-09-24
37613327090902NA92-8170892-817082015-09-24
37613327090919NA92-8171092-817102015-09-24
37613327090926NA92-8171292-817122015-09-24
37613327090940NA92-8190592-819052015-09-24
07613327579840N/A7000015775847000015775842025-09-08
07613327680522NA92-5553192-555312025-07-31
07613327651461NA92-0551292-055122025-07-09
07613327504385NA92-0233392-023332020-05-12
07613327504392NA92-0233292-023322020-05-12
07613327353563NA6002-140-2006002-140-2002025-02-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00873263009468microTargeting™ PlatformFHC, INC.HAW2026-03-16
00873263009475microTargeting™ Measurement ProbeFHC, INC.HAW2026-03-16
08800050904769Geniant CranialKOH YOUNG TECHNOLOGY INC.HAW2026-03-09
08800050904776Geniant CranialKOH YOUNG TECHNOLOGY INC.HAW2026-03-09
00889024704213PLANNING STATION - USAMEDTECHHAW2026-02-23
00763000738334AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
00763000738341AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
00763000738402AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
00763000738433AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
04056481147808Drill Depth Stop Cranial 4.9 mmBrainlab SEHAW2026-02-11
00873263009451microTargeting™ Drill GuideFHC, INC.HAW2026-02-10
00860009258105COMPASS CYGNUS-PFS IGS SystemCompass InternationalHAW2026-01-29
00860009258112COMPASS Stereotactic SystemCompass InternationalHAW2026-01-29
07630345728975Navigation System for Knee surgeryMedacta International SAHAW2026-01-26
07630699701792Navigation System for Knee surgeryMedacta International SAHAW2026-01-26
00873263009574STar™ Drive Frame AdapterFHC, INC.HAW2026-01-25
07630030846656Navigation System for Knee surgeryMedacta International SAHAW2026-01-19
07630030846663Navigation System for Knee surgeryMedacta International SAHAW2026-01-19
00763000738488AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-01-01
00860012211906SOLOPASS 2.0 Patient Interface DeviceinTRAvent Medical Partners, L.P.HAW2025-12-11
00763000337292N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000337308N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000337315N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000337322N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000340261N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000405144N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000405151N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000927264MedtronicMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000943219N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
07340201502273Leksell Stereotactic SystemElekta Solutions ABHAW2025-09-17