FDA.reportPublic FDA data

LinkBio Instrument

Primary DI
00810022403020
Brand
LinkBio Instrument
Company
Link Bio Corp
Model
87-1401
Device description
Fusion Nail Tibial Trial
Published
2023-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810022403020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810022403020008100224030208100224030200810022403020

GMDN Terms#

Term, Definition table
TermDefinition
Knee stem prosthesis trialA copy of a final femur or tibia stem prosthesis designed to be used during knee arthroplasty (TKA) to determine the correct size of the final prosthesis. It is one of a set, or a set, of graduated sizes and is typically made of metal or polymer material. 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
827608774
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
00810022403433LinkBio Instrument87-2003/012026-06-08
00810022403440LinkBio Instrument87-2003/022026-06-08
00810022403457LinkBio Instrument87-2003/032026-06-08
00810022403037LinkBio Instrument87-14022023-03-28
00810022403044LinkBio Instrument87-14032023-03-28
00810022402986LinkBio Instrument87-1912/012022-06-10
00810022402993LinkBio Instrument87-1912/022022-06-10
00810022403006LinkBio Instrument87-1912/032022-06-10
00810022403013LinkBio Instrument87-1912/042022-06-10
00810022403051CORE Shoulder System87-91312025-06-04
00810022403068CORE Shoulder System87-91322025-06-04
00810022403082CORE Shoulder System87-91392025-06-04
00810022403099CORE Shoulder System87-91362025-06-04
00810022403105CORE Shoulder System87-91372025-06-04
00810022403112CORE Shoulder System87-91382025-06-04
00810022403129CORE Shoulder System87-9133/16L2025-06-04
00810022403136CORE Shoulder System87-9133/20L2025-06-04
00810022403143CORE Shoulder System87-9133/24L2025-06-04
00810022403150CORE Shoulder System87-9133/28L2025-06-04
00810022403167CORE Shoulder System87-9133/16R2025-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982350596VOLTSynthes GmbHHWT2026-09-25
10886982350602VOLTSynthes GmbHHWT2026-09-25
10886982350619VOLTSynthes GmbHHWT2026-09-25
10886982350626VOLTSynthes GmbHHWT2026-09-25
10886982350695VOLTSynthes GmbHHWT2026-09-25
10886982350701VOLTSynthes GmbHHWT2026-09-25
10886982350718VOLTSynthes GmbHHWT2026-09-25
00840606191326PrimusSPINAL ELEMENTS, INC.HWT2026-09-22
03701313009502K-RODS.M.A.I.OHWT2026-09-22
10888857298590ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
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