Osseoflex SB
FDA 510(k) K140937 · Osseon, LLC
510(k) numberK140937
Submission
- Device name
- Osseoflex SB
- Applicant
- Osseon, LLC
Santa Rosa, CA, US - Received
- April 11, 2014
- Decision date
- June 19, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Osseoflex SB cleared by the FDA?
Osseoflex SB (K140937) received a 510(k) decision of Substantially Equivalent on June 19, 2014, 69 days after the submission was received.
What is the product code of K140937?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.