FDA.reportPublic FDA data

Trial Cup

Primary DI
08053689762402
Brand
Trial Cup
Company
ADLER ORTHO SPA
Model
Trial Cup
Catalog number
IP40056
Device description
TRIAL CUP W/2 HOLES SIZE 56
Published
2025-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08053689762402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053689762402080536897624028053689762402

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
338847291
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052693621545Tibial ImpactorKP07340KP073402025-11-03
08052693621552Femoral ImpactorKP07350KP073502025-11-03
08053617185211PunchKZ03312KZ033122025-10-08
08053617185228PunchKZ03334KZ033342025-10-08
08053617185235PunchKZ03356KZ033562025-10-08
08056269043618Trial Tibial AugmentKZ00507KZ005072025-11-03
08056269043625Trial Tibial AugmentKZ00527KZ005272025-11-03
08056269044080Trial Tibial AugmentKZ00501KZ005012025-11-03
08056269044097Trial Tibial AugmentKZ00502KZ005022025-11-03
08056269044103Trial Tibial AugmentKZ00503KZ005032025-11-03
08056269044110Trial Tibial AugmentKZ00504KZ005042025-11-03
08056269044127Trial Tibial AugmentKZ00505KZ005052025-11-03
08056269044134Trial Tibial AugmentKZ00506KZ005062025-11-03
08056269044141Trial Tibial AugmentKZ00521KZ005212025-11-03
08056269044158Trial Tibial AugmentKZ00522KZ005222025-11-03
08056269044165Trial Tibial AugmentKZ00523KZ005232025-11-03
08056269044172Trial Tibial AugmentKZ00524KZ005242025-11-03
08056269044189Trial Tibial AugmentKZ00525KZ005252025-11-03
08056269044196Trial Tibial AugmentKZ00526KZ005262025-11-03
08056269044202Trial Tibial AugmentKZ01001KZ010012025-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091001ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091018ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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00841523181810Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
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