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Anchorage Bone Plating System

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K172148Ref XVIMQ001045Model 08858251002528SZ

by Stryker GmbH

Identity

Trade Name
ANCHORAGE EUDAMEDFDA UDI
Generic Name
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name
ANCHORAGE INSTRUMENTS - INSTRUMENTATION SLEEVES - CLASS I - REUSABLE - NON STERILE EUDAMED
Polyaxial Cross Plate FDA UDI
Model / Reference
XVIMQ001045 EUDAMEDFDA UDI
08858251002528SZ EUDAMED
Description
Polyaxial Cross Plate FDA UDI

Identifiers

Catalog Number
XVIMQ001045 FDA UDI
Primary DI / UDI-DI
07613252267058 EUDAMEDFDA UDI
Basic UDI-DI
08858251002528SZ EUDAMED
510(k) Number
K172148 FDA 510(k)
FDA Product Code
HRS FDA 510(k)
LXH FDA UDI
EMDN Code
P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES EUDAMED
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
888.4540 FDA UDI
Market of Registration
Netherlands EUDAMED
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

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

The Anchorage Bone Plating System is a surgical orthopedic device classified as a bone plate, designed for internal fixation of long bone fractures. It stabilizes bone fragments through rigid plating, facilitating proper alignment and healing by distributing mechanical loads across the fracture site.

This system is supplied sterile and intended for single-use in orthopedic surgical settings. It is approved for use under FDA 510K clearance (K172148) and meets MDR requirements, with no MRI safety restrictions specified. Available in various sizes and configurations, it is stored in its original packaging until use to maintain sterility.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stryker GmbH

Sources (3)

  • FDA 510(k) K172148 24 fields · synced Sep 18, 2026
  • FDA UDI ca2596fc-1daa-4103-adab-52d0bb56815f 34 fields · synced May 30, 2026
  • EUDAMED b10bc613-a2a3-4dff-accf-126d64b462c8 61 fields · synced Sep 17, 2026