Michelangelo Bunion System - Mabs, Model: MA6000
FDA 510(k) K091763 · Instratek, Inc.
510(k) numberK091763
Submission
- Device name
- Michelangelo Bunion System - Mabs, Model: MA6000
- Applicant
- Instratek, Inc.
Spring, TX, US - Received
- June 16, 2009
- Decision date
- August 14, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Michelangelo Bunion System - Mabs, Model: MA6000 cleared by the FDA?
Michelangelo Bunion System - Mabs, Model: MA6000 (K091763) received a 510(k) decision of Substantially Equivalent on August 14, 2009, 59 days after the submission was received.
What is the product code of K091763?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.