← Back to catalogue

Monterey™ AL

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
Monterey™ AL FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
M/L AL Implant Inserter 10/12 mm FDA UDI
Model / Reference
PRO-1418-02 FDA UDI
Description
M/L AL Implant Inserter 10/12 mm FDA UDI

Identifiers

Catalog Number
PRO-1418-02 FDA UDI
Primary DI / UDI-DI
10888857586932 FDA UDI
510(k) Number
K201585 FDA UDI
FDA Product Code
OVD FDA UDI
MAX FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Monterey™ AL by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Cleared under the same submission

K201585 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI a02d5966-22d4-4393-8e2e-0406ce03a0d9 36 fields · synced May 30, 2026