FDA.reportPublic FDA data

Knee Instruments

Primary DI
07630030878213
Brand
Knee Instruments
Company
Medacta International SA
Model
11.00025
Device description
Tibial FIXED STD-PS S5 Instrument Set
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630030878213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630030878213076300308782137630030878213

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
488227125
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630699705950Shoulder System04.01.10.12142026-10-01
07630699705967Shoulder System04.01.10.12152026-10-01
07630699705974Shoulder System04.01.10.12162026-10-01
07630699705998Shoulder System04.01.10.12182026-10-01
07630699706001Shoulder System04.01.10.12192026-10-01
07630699706018Shoulder System04.01.10.12202026-10-01
07630699706032Shoulder System04.01.10.12222026-10-01
07630699706049Shoulder System04.01.10.12232026-10-01
07630699706056Shoulder System04.01.10.12242026-10-01
07630345775320Shoulder System04.01.10.06972026-09-28
07630345775375Shoulder System04.01.10.07022026-09-28
07630542727528Shoulder System04.01.10.08812026-09-28
07630542727535Shoulder System04.01.10.08822026-09-28
07630542727542Shoulder System04.01.10.08832026-09-28
07630542727559Shoulder System04.01.10.08842026-09-28
07630542794964Surgical Manual Instrument04.01.10.10132026-09-28
07630542794971Surgical Manual Instrument04.01.10.10142026-09-28
07630542794988Surgical Manual Instrument04.01.10.10152026-09-28
07630542794995Surgical Manual Instrument04.01.10.10162026-09-28
07630542795008Shoulder System04.01.10.10172026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894827723AVENGERMedartis AGLXH2026-10-13
07630894827730AVENGERMedartis AGLXH2026-10-13
07630894827747AVENGERMedartis AGLXH2026-10-13
00190776434762MillenniumAvalign Technologies, Inc.LXH2026-10-12
00850080243176OSTEOROD Delivery SystemBONE SOLUTIONS, INC.LXH2026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-10-12
00724995225148NASTERIS CORPORATIONLXH2025-03-31
00196449010219A.L.P.S. mvX™Tyber Medical, LLCLXH2023-12-15
00196449012800A.L.P.S. mvX™Tyber Medical, LLCLXH2023-12-15
B0842002000400Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000410Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000420Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000430Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000440Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000450Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000460Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000470Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000480Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000490Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000500Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000600Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000610Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000620Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000630Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000640Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000650Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000660Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000670Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000680Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000690Keos Lumbar InstrumentKEOSLXH2023-02-07