FDA.reportPublic FDA data

Tibial Trial Inserter

Primary DI
00854515008873
Brand
Tibial Trial Inserter
Company
Unique Surgical
Model
Medacta
Published
2025-08-07
Public version status
New
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
00854515008873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854515008873008545150088738545150088730854515008873

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
818-813-8527info@UniqueSurgical.com

Regulatory Flags#

DUNS number
079820535
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
00850080482063Drill BitBayonet Drill Bit Ø3.2 L152026-01-30
00850080482070Drill BitBayonet Drill Bit Ø3.2 L202026-01-30
00850080482087Drill BitBayonet Drill Bit Ø3.2 L252026-01-30
00850080482094Drill BitBayonet Drill Bit Ø3.2 L302026-01-30
00850080482100Drill BitBayonet Drill Bit Ø3.2 L352026-01-30
00850080482117Drill BitBayonet Drill Bit Ø3.2 L402026-01-30
00850080482124Drill BitBayonet Drill Bit Ø3.2 L452026-01-30
00850080482131Drill BitBayonet Drill Bit Ø3.2 L502026-01-30
00850080482148Drill BitBayonet Drill Bit Ø3.2 L552026-01-30
00850080482155Drill BitBayonet Drill Bit Ø3.2 L602026-01-30
00850080482162Drill BitBayonet Drill Bit Ø3.2 L652026-01-30
00850080482179Drill BitBayonet Drill Bit Ø3.2 L702026-01-30
00850080482186Drill BitBayonet Drill Bit Ø3.2 L752026-01-30
00850080482193Drill BitBayonet Drill Bit Ø3.2 L802026-01-30
00854515008002ImpactorFemoral2023-01-06
00854515008989Medacta Glenosphere Impactor TipCannulated2025-09-16
00854515008927ScrewdriverU-Joint, 3.5mm Hex, Hudson Connector2025-08-07
00854515008934ScrewdriverSolid Shaft, 3.5mm Hex, Hudson Connector2025-08-07
00850080482025Screw ForcepsMedacta, with Cap2025-12-18
00850080482032Bone PinMedacta, Fluted2025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150002139N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00199150002146N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754730N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754747N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00822409082124N/AOrtho Development CorporationLXH2026-07-16
00822409082131N/AOrtho Development CorporationLXH2026-07-16
00822409082148N/AOrtho Development CorporationLXH2026-07-16
00822409082155N/AOrtho Development CorporationLXH2026-07-16
00822409082162N/AOrtho Development CorporationLXH2026-07-16
00822409082179N/AOrtho Development CorporationLXH2026-07-16
00822409082186N/AOrtho Development CorporationLXH2026-07-16
00822409082193N/AOrtho Development CorporationLXH2026-07-16
00822409082209N/AOrtho Development CorporationLXH2026-07-16
00822409082216N/AOrtho Development CorporationLXH2026-07-16
00822409082223N/AOrtho Development CorporationLXH2026-07-16
00822409082230N/AOrtho Development CorporationLXH2026-07-16
00822409082247N/AOrtho Development CorporationLXH2026-07-16
00822409082254N/AOrtho Development CorporationLXH2026-07-16
00822409082261N/AOrtho Development CorporationLXH2026-07-16
00822409082278N/AOrtho Development CorporationLXH2026-07-16
00822409082285N/AOrtho Development CorporationLXH2026-07-16
00822409082292N/AOrtho Development CorporationLXH2026-07-16
00822409082308N/AOrtho Development CorporationLXH2026-07-16
00822409082315N/AOrtho Development CorporationLXH2026-07-16
00822409082322N/AOrtho Development CorporationLXH2026-07-16
00822409082339N/AOrtho Development CorporationLXH2026-07-16
00822409082346N/AOrtho Development CorporationLXH2026-07-16
00840606188135Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188142Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188159Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16