TiTHON Staple with OsseoTi Technology
FDA 510(k) K151615 · Biomet Manufacturing Corp
510(k) numberK151615
Submission
- Device name
- TiTHON Staple with OsseoTi Technology
- Applicant
- Biomet Manufacturing Corp
Warsaw, IN, US - Received
- June 15, 2015
- Decision date
- October 2, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K240212 | COGNiTiON Staple SystemJDR · Special | Ortho Solutions UK , Ltd. | 02/23/2024SE |
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Questions and answers
When was TiTHON Staple with OsseoTi Technology cleared by the FDA?
TiTHON Staple with OsseoTi Technology (K151615) received a 510(k) decision of Substantially Equivalent on October 2, 2015, 109 days after the submission was received.
What is the product code of K151615?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.