FDA.reportPublic FDA data

Orthopedic Manual Surgical Instrument

Primary DI
04719875721243
Brand
Orthopedic Manual Surgical Instrument
Company
WILTROM CO., LTD.
Model
75046 Pin M1.2*L121mm
Device description
Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic procedures to assist implantation of Wiltrom implants. The Wiltrom Orthopedic Surgical Instruments are provided non-sterile and must be sterilized prior to use.
Published
2022-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
04719875721243PrimaryGS10
04719875729751Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719875721243047198757212434719875721243
04719875729751047198757297514719875729751

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature23 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+88636107168service@wiltrom.com.tw

Regulatory Flags#

DUNS number
656680902
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873027378Wiltrom Spinal Fixation System40044005 Cross-Link Nut ø=6.0 L=4.52022-11-17
04719873027361Wiltrom Spinal Fixation System43040000 Nut ø=9.5 L=4.62022-11-14
04719873024223WILTROM SPINAL FIXATION SYSTEM43555035 Polyaxial Pedicle Screw ø=5.0 / L=352019-09-10
04719873024216WILTROM SPINAL FIXATION SYSTEM43555030 Polyaxial Pedicle Screw ø=5.0 / L=302019-05-10
04719875729843Wiltrom Spinal Fixation System43587550 Polyaxial Reduction Pedicle Screw, Cannul2023-10-11
04719875729850Wiltrom Spinal Fixation System43587555 Polyaxial Reduction Pedicle Screw, Cannul2023-10-11
04719875729867Wiltrom Spinal Fixation System43587560 Polyaxial Reduction Pedicle Screw, Cannul2023-10-11
04719875729874Wiltrom Spinal Fixation System43587565 Polyaxial Reduction Pedicle Screw, Cannul2023-10-11
04719875729881Wiltrom Spinal Fixation System43587570 Polyaxial Reduction Pedicle Screw, Cannul2023-10-11
04719873025299Wiltrom Spinal Fixation System43577030 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025305Wiltrom Spinal Fixation System43577035 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025312Wiltrom Spinal Fixation System43577040 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025329Wiltrom Spinal Fixation System43577045 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025336Wiltrom Spinal Fixation System43577050 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025343Wiltrom Spinal Fixation System43577055 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025350Wiltrom Spinal Fixation System43577060 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025367Wiltrom Spinal Fixation System43577065 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025374Wiltrom Spinal Fixation System43577070 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025381Wiltrom Spinal Fixation System43577530 Polyaxial Reduction Pedicle Screw ø=7.5 L2022-11-30
04719873025398Wiltrom Spinal Fixation System43577535 Polyaxial Reduction Pedicle Screw ø=7.5 L2022-11-30

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