FDA.report

57x28mm Locking Polarcup Trial

Primary DI
09421028112802
Brand
57x28mm Locking Polarcup Trial
Company
ENZTEC LIMITED
Model
35130036
Catalog number
35130036
Device description
A surgical instrument representative of the definitive implant, intended to be used during an orthopaedic surgical procedure to assist in the selection of the correct size and/or position of the definitive implant.
Published
2023-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HWTTemplate

Product Code Classifications

CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09421028112802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09421028112802094210281128029421028112802

GMDN Terms

TermDefinition
Acetabulum prosthesis trial, prefabricated, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
592616445
Device count
1
DM exempt
false
Premarket exempt
true
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
true

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09421038412152Offset coupling, Z/H9209-13069209-13062026-03-09
09421038412169Offset drive train, locking9209-13039209-13032026-03-09
09421038412176Short Offset Cover – United9209-13079209-13072026-03-09
09421038412183Handle – United9209-13059209-13052026-03-09
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09421038412305Offset coupling, AO9209-13139209-13132026-03-09
09421038412312Cup reamer handle, offset, AO, open9209-13129209-13122026-03-09
09421038412329Offset drive train, open9209-13049209-13042026-03-09
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09421038411919Sagittal Alignment Connector - Pivot with Fan4240-77064240-77062026-02-27
09421038411926Dist Fem Cut Block Connector – 8mm4240-77104240-77102026-02-27
09421038411933Dist Fem Cut Block Connector – 9mm4240-77114240-77112026-02-27
09421038411940Dist Fem Cut Block Connector – 10mm4240-77124240-77122026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mm4240-77254240-77252026-02-27

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