Stryker Total Performance (TPS) System
FDA 510(k) K032117 · Stryker Instruments
510(k) numberK032117
Submission
- Device name
- Stryker Total Performance (TPS) System
- Applicant
- Stryker Instruments
Kalamazoo, MI, US - Received
- July 9, 2003
- Decision date
- August 8, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Stryker Total Performance (TPS) System cleared by the FDA?
Stryker Total Performance (TPS) System (K032117) received a 510(k) decision of Substantially Equivalent on August 8, 2003, 30 days after the submission was received.
What is the product code of K032117?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.