Lynx

FDA UDI

Class II (US FDA UDI)

by Hnm Total Recon Llc

Identity

Trade Name: LYNX FDA UDI
Generic Name: Implantable bone washer FDA UDI
Device Name: LYNX Washer,Ti (For ø2.7mm/ø3.5mm Screw) FDA UDI
Model / Reference: HTR-02-600211 FDA UDI
Description: LYNX Washer,Ti (For ø2.7mm/ø3.5mm Screw) FDA UDI

Identifiers

Catalog Number: HTR-02-600211 FDA UDI
Primary DI / UDI-DI: 00841742111308 FDA UDI
510(k) Number: K102845 FDA UDI
FDA Product Code: HTY FDA UDI
GMDN Term: Implantable bone washer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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

MRI Safety

MR Safe FDA UDI

Category: Implantable bone washer

Lynx by Hnm Total Recon Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable bone washer.

ISOLA — Depuy Spine, Inc. · Class II
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Monster Screw System — Paragon 28 · Class II
ALPHALOK Plating System — Vilex, Inc. · Class II
Monster Screw System — Paragon 28 · Class II
FLAT WASHER — Biomet Orthopedics, Inc. · Class II
Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
LEOS Cannulated Screw System — Tyber Medical · Class II

Cleared under the same submission

K102845 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Hnm Total Recon Llc

Sources (1)

FDA UDI dd12bbc9-f65b-486c-8f2f-b5d870e0e357 35 fields · synced May 30, 2026