FDA.reportPublic FDA data

RPS

Primary DI
07613327631814
Brand
RPS
Company
Stryker Leibinger GmbH & Co. KG
Model
8800800000
Catalog number
8800-800-000
Device description
PRIMARY TKA SOFTWARE
Published
2025-10-03
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327631814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327631814076133276318147613327631814

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.

Contacts#

Phone, Email table
PhoneEmail
+0018002533210inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
316153956
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252578208NA78-2102878-210282015-07-03
07613252578215NA78-2002878-200282015-07-03
07613252578222NA78-2002078-200202015-07-03
07613252578239NA78-2102078-210202015-07-03
07613252599647NA78-3002078-300202015-07-03
07613252599654NA78-3002878-300282015-07-03
07613252599661NA78-3102078-310202015-07-03
07613252599678NA78-3102878-310282015-07-03
07613327392715DELTA70-7620170-762012018-06-07
04546540364883NA50-1290050-129002023-02-13
07613327369489AXS62-1217862-121782019-09-11
04546540246332NA60-1010460-101042016-08-24
04546540246356NA60-1010860-101082016-08-24
04546540246387NA60-1011260-101122016-08-24
04546540256805NA62-0053462-005342016-10-19
04546540258991NA62-1740162-174012016-10-19
04546540274175NA64-0010564-001052016-12-08
04546540274250NA64-0013264-001322017-01-11
04546540356758NA64-0024264-002422016-12-08
04546540356765NA64-0024364-002432016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCOLO2026-08-03
00840606195546Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195553Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195560Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195577Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195584Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195591Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195607Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195614Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195621Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195638Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195645Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30