Cannulated Screw System
FDA 510(k) K003496 · Pioneer Surgical Technology
510(k) numberK003496
Submission
- Device name
- Cannulated Screw System
- Applicant
- Pioneer Surgical Technology
Marquette, MI, US - Received
- November 13, 2000
- Decision date
- February 8, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Cannulated Screw System cleared by the FDA?
Cannulated Screw System (K003496) received a 510(k) decision of Substantially Equivalent on February 8, 2001, 87 days after the submission was received.
What is the product code of K003496?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.