FDA.reportPublic FDA data

Wiltrom Spinal Fixation System

Primary DI
04719873025343
Brand
Wiltrom Spinal Fixation System
Company
WILTROM CO., LTD.
Model
43577055 Polyaxial Reduction Pedicle Screw ø=7.0 L
Device description
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments thatallow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom SpinalFixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants aremade of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile,and the implants are for single use only.
Published
2022-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202894000Wiltrom Spinal Fixation SystemWiltrom Corporation Limited2020-10-23NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873025343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873025343047198730253434719873025343

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
1
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
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
04719873025404Wiltrom Spinal Fixation System43577540 Polyaxial Reduction Pedicle Screw ø=7.5 L2022-11-30

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Primary DI, Brand, Company table
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