LinkBio Instrument

FDA UDI

Class I (US FDA UDI)

by LinkBio Corp.

Identity

Trade Name: LinkBio Instrument FDA UDI
Generic Name: Bone-resection orthopaedic reamer, reusable FDA UDI
Device Name: Reamer Template, Tibial Cone XS/S FDA UDI
Model / Reference: 87-1907/01 FDA UDI
Description: Reamer Template, Tibial Cone XS/S FDA UDI

Identifiers

Primary DI / UDI-DI: 00810022402375 FDA UDI
FDA Product Code: LXH FDA UDI
HWE FDA UDI
HWT FDA UDI
GMDN Term: Bone-resection orthopaedic reamer, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
878.4820 FDA UDI
888.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone-resection orthopaedic reamer, reusable

LinkBio Instrument by LinkBio Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-resection orthopaedic reamer, reusable.

InSitu Hip System — Nextstep Arthropedix · Class I
Tornier Perform — TORNIER, INC. · Class I
Arcos® STS™ Modular Revision System — Biomet Orthopedics, Inc. · Class II
Vanguard® — Biomet Orthopedics, Inc. · Class I
Trigen — Smith & Nephew, Inc. · Class I
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
Made-To-Order — TORNIER, INC. · Class I
LINK Instruments - Drills, reamers and saw blades — WALDEMAR LINK GmbH & Co. KG · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: LinkBio Corp.

Sources (1)

FDA UDI 1acd6445-e215-46af-a870-7f8b5a77ee5e 33 fields · synced Jun 1, 2026