FDA.reportPublic FDA data

ORTHOMAP

Primary DI
07613252433521
Brand
ORTHOMAP
Company
Stryker Leibinger GmbH & Co. KG
Model
6003-672-100
Catalog number
6003-672-100
Device description
ORTHOMAP¿ EXPRESS KNEE 2.0 - UPGRADE
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
false

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252433521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252433521076132524335217613252433521

GMDN Terms#

Term, Definition table
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.

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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327626551Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG0102023-09-11
07613327626568Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG0262023-09-11
07613327626575Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG0202023-09-11
07613327626605Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG0242023-09-11
07613252448778ORTHOMAP6003-655-1006003-655-1002017-12-12
04546540717443ORTHOMAP6003-655-0006003-655-0002017-12-12
07613154272105HYDROSET3970033970032015-09-24
07613154272112HYDROSET3970053970052015-09-24
07613154272129HYDROSET3970103970102015-09-24
07613154272136HYDROSET3970153970152015-09-24
07613154274994HYDROSET79-4390379-439032015-09-24
07613154275007HYDROSET79-4390579-439052015-09-24
07613154275014HYDROSET79-4391079-439102015-09-24
07613154275021HYDROSET79-4391579-439152015-09-24
07613154804764HYDROSET3970233970232015-09-24
07613154804771HYDROSET3970213970212015-09-24
07613154804788HYDROSET7070017070012015-09-24
07613154888153HYDROSET3970273970272015-09-24
07613252510673CRANIALMAP6000-655-1006000-655-1002016-08-24
07613252510703CRANIALMAP6000-655-1506000-655-1502016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705034648194VELYSMedos International SàrlOLO2026-10-09
10705034648200VELYSMedos International SàrlOLO2026-10-09
00885556924327Real IntelligenceSmith & Nephew, Inc.OLO2026-10-08
00810055525225Onyx 4.5 mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525232Onyx 5.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525249Onyx 6.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525256Onyx 7.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525263Onyx 4.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525270Onyx 5.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525287Onyx 6.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525294Onyx 7.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525720Onyx Navigated Locking DriverSi-Bone Inc.OLO2026-09-30
00810055525966Onyx Navigated Locking Driver, CannulatedSi-Bone Inc.OLO2026-09-30
00810055526284Onyx iGPS Awl Tip Tap 4.5mmSi-Bone Inc.OLO2026-09-30
00810055526291Onyx iGPS Awl Tip Tap 5.5mmSi-Bone Inc.OLO2026-09-30
00810055526307Onyx iGPS Awl Tip Tap 6.5mmSi-Bone Inc.OLO2026-09-30
00810055526314Onyx iGPS Awl Tip Tap 7.5mmSi-Bone Inc.OLO2026-09-30
00810055526321Onyx iGPS DriverSi-Bone Inc.OLO2026-09-30
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