FDA.report

ORTHOMAP

Primary DI
07613252448778
Brand
ORTHOMAP
Company
Stryker Leibinger GmbH & Co. KG
Model
6003-655-100
Catalog number
6003-655-100
Device description
ORTHOMAP¿ PRECISION KNEE 5.0 - UPGRADE
Published
2017-12-12
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
false

Related Records

Product Codes

CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications

CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613252448778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613252448778076132524487787613252448778

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
false
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
00193982622312EXCELSIUSGPSGLOBUS MEDICAL, INC.OLO2026-03-24
00193982622329EXCELSIUSGPSGLOBUS MEDICAL, INC.OLO2026-03-24
00199150024469INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-03-22
00199150024483INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-03-22
00199150038138INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-03-21
00885556919712Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919729Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919743Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919750Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919767Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919774Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924198Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924204Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924211Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924228Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924235Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924242Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924266Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924273Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924297Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
20885556924307NASmith & Nephew, Inc.OLO2026-03-10
07613327627725MakoMAKO SURGICAL CORP.OLO2026-03-10
00840493413228RIVA Posterior Fixation SystemXENIX MEDICAL LLCOLO2026-03-03
07613327683653Shoulder 1.5 Installation DiskMAKO SURGICAL CORP.OLO2026-03-03
10888857563384Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563391Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563407Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563414Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563421Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857578876Q Interbody InstrumentsK2M, INC.OLO2026-03-03