Stryker Power Tool Navigator Attachment
510(k) K080450
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK080450 | Date17 Jul 2008 | StatusActive |
Official records
- FDA 510(k) database K080450
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HAW
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Stryker Power Tool Navigator Attachment is an optical surgical navigation tracker attachment for Stryker surgical power tools. It utilizes an array of optical IR LEDs and an IR communications link to interface with the Stryker Navigation System, enabling the system to track tool position in 3D space during surgical procedures.
The device outputs data that allows the surgeon to visualize tool location relative to patient anatomy. It is supplied as part of a surgical navigation system and is used in conjunction with Stryker power tools. The device received FDA 510(k) clearance (K080450) and is classified under product code HAW. It is manufactured by Stryker Corp. and is intended for use in surgical settings where navigation tracking of power tools is required.