PYRENEES® Cervical Plate System

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name: PYRENEES® Cervical Plate System FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: Slotted Constrained Plate, 2 Level FDA UDI
Model / Reference: 208-42F42A FDA UDI
Description: Slotted Constrained Plate, 2 Level FDA UDI

Identifiers

Catalog Number: 208-42F42A FDA UDI
Primary DI / UDI-DI: 10888857214026 FDA UDI
FDA Product Code: KWQ FDA UDI
KWP FDA UDI
MNI FDA UDI
NKB FDA UDI
OSH FDA UDI
MNH FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
888.3050 FDA UDI
888.3070 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

Yes

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

Dimensions & Sizes

Size: Length — 42 Millimeter FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

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

Similar devices

Also classified as Spinal fixation plate, non-bioabsorbable.

Zavation — ZAVATION · Class II
Cervalign — Xtant Medical Holdings, Inc. · Class II
CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc. · Class II
TSLP — Synthes · Class II
AESCULAP — AESCULAP, INC. · Class II
PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
ACP — Nuvasive, Inc. · Class II
uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II

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

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

Manufacturer

Manufacturer: K2m, Inc.

Sources (1)

FDA UDI 3b505d28-f0fa-4665-80a5-1023165e4466 36 fields · synced Jun 1, 2026