Orthosorb LS
FDA 510(k) K140625 · Biomet, Inc.
510(k) numberK140625
Submission
- Device name
- Orthosorb LS
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- March 11, 2014
- Decision date
- April 18, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVZ – Pin, Fixation, Resorbable, Hard Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.
Other 510(k)s with product code OVZ
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Questions and answers
When was Orthosorb LS cleared by the FDA?
Orthosorb LS (K140625) received a 510(k) decision of Substantially Equivalent on April 18, 2014, 38 days after the submission was received.
What is the product code of K140625?
The FDA product code is OVZ – Pin, Fixation, Resorbable, Hard Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.