NeoSpan Compression Staple Impant w/instruments
FDA 510(k) K161426 · In2bones USA, LLC
510(k) numberK161426
Submission
- Device name
- NeoSpan Compression Staple Impant w/instruments
- Applicant
- In2bones USA, LLC
Memphis, TN, US - Received
- May 23, 2016
- Decision date
- October 24, 2016
- 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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Questions and answers
When was NeoSpan Compression Staple Impant w/instruments cleared by the FDA?
NeoSpan Compression Staple Impant w/instruments (K161426) received a 510(k) decision of Substantially Equivalent on October 24, 2016, 154 days after the submission was received.
What is the product code of K161426?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.