PYRENEES® Cervical Plate System

FDA UDI

Class I (US FDA UDI)

by K2m, Inc.

Identity

Trade Name: PYRENEES® Cervical Plate System FDA UDI
Generic Name: Bone-resection orthopaedic reamer, single-use FDA UDI
Device Name: Reamer, Size 5 mm FDA UDI
Model / Reference: 6808-90016 FDA UDI
Description: Reamer, Size 5 mm FDA UDI

Identifiers

Catalog Number: 6808-90016 FDA UDI
Primary DI / UDI-DI: 10888857261693 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Bone-resection orthopaedic reamer, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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, single-use

PYRENEES® Cervical Plate System by K2m, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-resection orthopaedic reamer, single-use.

RAZOR Single-Use Acetabular Reamer — Razor Medical Instruments, Inc. · Class I
RAZOR Single-Use Acetabular Reamer — Razor Medical Instruments, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
Disposable — Biomet Orthopedics, Inc. · Class I
PANTA® — Newdeal Sas · Class I
ACETABULAR REAMER EVO 2 Ti CUP D42 mm — HPF SRL · Class I
Arthrex® — Arthrex, Inc. · Class I
Tools - UFC — Trimed, INC. · 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: K2m, Inc.

Sources (1)

FDA UDI b0ca5a77-126b-4c26-9936-43f55b381d53 35 fields · synced Jun 1, 2026