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Anchorage 2 CP System

by Stryker GmbH

510(k) K151769

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151769↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK151769 Date27 Oct 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151769 decided 27 Oct 2015 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
HRS
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Anchorage 2 CP System is a spinal fixation device designed for internal orthopedic use, classified under the nomenclature for spinal instrumentation and internal fixation devices. It provides secure stabilization of the cervical spine through the use of screws, rods, and connectors to maintain alignment and promote proper healing in spinal procedures.

This system is supplied sterile and intended for single-use, though components may be reusable under specific reprocessing protocols as per manufacturer guidelines. It is intended for use in operating rooms and is compatible with MRI environments as per the manufacturer’s safety data. The system is authorized for commercial distribution in the United States under FDA 510(k) clearance (K151769) and meets MDR requirements in applicable markets. Proper storage and handling are critical to maintain sterility and functionality.

Similar devices

Other devices filed under FDA product code HRS (Plate, Fixation, Bone).

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