FDA.reportPublic FDA data

LinkBio Instrument

Primary DI
00810022402801
Brand
LinkBio Instrument
Company
Link Bio Corp
Model
87-1903/12
Device description
Broach, Tibial Cone S Full
Published
2022-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTQBroach
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTQBroachOrthopedic1
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810022402801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810022402801008100224028018100224028010810022402801

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

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
00810022403020LinkBio Instrument87-14012023-03-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200103096ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103102ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103119ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103126ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103133ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103140ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103157ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103164ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103522ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103539ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103546ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103553ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103560ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103577ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103584ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103591ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103607ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103614ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103782ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103799ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103805ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103812ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103829ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103836ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103843ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103850ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103867ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103935ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103942ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103959ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17