Framelock; Framelock Accessories
FDA 510(k) K022370 · Medtronic Xomed, Inc.
510(k) numberK022370
Submission
- Device name
- Framelock; Framelock Accessories
- Applicant
- Medtronic Xomed, Inc.
Jacksonville, FL, US - Received
- July 22, 2002
- Decision date
- October 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Framelock; Framelock Accessories cleared by the FDA?
Framelock; Framelock Accessories (K022370) received a 510(k) decision of Substantially Equivalent on October 18, 2002, 88 days after the submission was received.
What is the product code of K022370?
The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.