Anchorage 2 CP System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Stryker GmbH
Identity
- Trade Name
- Anchorage® 2 CP EUDAMEDANCHORAGE FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- ANCHORAGE 2 CP - SCREWS - TITANIUM ALLOY - CLASS IIB - NON STERILE EUDAMEDANCHORAGE 2 CP - SCREWS - TITANIUM ALLOY - CLASS IIB - STERILE EUDAMEDCP Lag Screw (T8) FDA UDI
- Model / Reference
- 626934S EUDAMEDFDA UDI626924 EUDAMEDFDA UDI08858251004802TC EUDAMED08858251006785UK EUDAMED
- Description
- CP Lag Screw (T8) FDA UDI
Identifiers
- Catalog Number
- 626934S FDA UDI626924 FDA UDI
- Primary DI / UDI-DI
- 07613327130973 EUDAMEDFDA UDI07613327130874 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251004802TC EUDAMED08858251006785UK EUDAMED
- 510(k) Number
- K151769 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)FDA UDIHWC FDA UDI
- EMDN Code
- P09120601 CORTICAL SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)FDA UDI888.3040 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
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 34.0 Millimeter FDA UDILength — 24.0 Millimeter FDA UDI
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.
Frequently asked questions
What types of spinal procedures is the Anchorage 2 CP System designed to support, and how does it provide stabilization?
The Anchorage 2 CP System is specifically designed for internal orthopedic use in cervical spine procedures. It achieves stabilization through a combination of screws, rods, and connectors, which work together to maintain proper alignment of the cervical vertebrae. This setup helps promote optimal healing by securing the spine in place during recovery.
Is the Anchorage 2 CP System intended for reuse, or is it strictly single-use? What are the manufacturer’s guidelines on reprocessing?
The Anchorage 2 CP System is supplied sterile and intended for single-use. However, certain components *may* be reusable if reprocessed according to the manufacturer’s (Stryker GmbH) specific guidelines. It’s important to follow these protocols to ensure safety and functionality, as improper reprocessing could compromise sterility or performance.
How should the Anchorage 2 CP System be stored to preserve its sterility and functionality?
The system must be stored under conditions that maintain sterility and prevent damage. Since it’s supplied sterile, it should be kept in its original packaging until ready for use. Proper storage also includes protecting it from moisture, extreme temperatures, and physical stress, as these factors could degrade the materials or compromise the sterile field.
Can the Anchorage 2 CP System be used in an MRI environment, and what safety considerations should be noted?
Yes, the Anchorage 2 CP System is compatible with MRI environments, but only under the manufacturer’s specified safety guidelines. Before use, clinicians should verify that the system meets MRI safety standards for the particular imaging protocol being used. Always refer to Stryker’s safety data for detailed compatibility and operational instructions.
What regulatory pathways has the Anchorage 2 CP System followed for commercial distribution in the U.S. and other markets?
In the United States, the Anchorage 2 CP System has received FDA 510(k) clearance under the classification for spinal instrumentation (K151769), demonstrating it is substantially equivalent to a predicate device. Internationally, it complies with MDR (Medical Device Regulation) requirements in applicable markets, ensuring it meets stringent EU standards for safety and performance.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151769 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker GmbH
Sources (5)
- FDA 510(k) K151769 24 fields · synced Sep 18, 2026
- FDA UDI 726cdd6f-64b8-4277-a776-245d11957b45 35 fields · synced May 30, 2026
- FDA UDI 70b6c99a-a3f5-4902-bc04-8d3c638615bd 35 fields · synced May 30, 2026
- EUDAMED a073e774-fed8-4967-89a0-b3c5246a385f 61 fields · synced Aug 1, 2026
- EUDAMED 0f1bd281-9a2a-46a1-b921-0d532a78e620 61 fields · synced Sep 17, 2026