Biopro - Infinity Plate Anchor System
FDA 510(k) K132510 · Biopro, Inc.
510(k) numberK132510
Submission
- Device name
- Biopro - Infinity Plate Anchor System
- Applicant
- Biopro, Inc.
Prior Lake, MN, US - Received
- August 12, 2013
- Decision date
- October 24, 2013
- 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 Biopro - Infinity Plate Anchor System cleared by the FDA?
Biopro - Infinity Plate Anchor System (K132510) received a 510(k) decision of Substantially Equivalent on October 24, 2013, 73 days after the submission was received.
What is the product code of K132510?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.