Sbi Stafix
FDA 510(k) K071479 · Small Bone Innovations, Inc.
510(k) numberK071479
Submission
- Device name
- Sbi Stafix
- Applicant
- Small Bone Innovations, Inc.
New York, NY, US - Received
- May 29, 2007
- Decision date
- August 2, 2007
- 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 Sbi Stafix cleared by the FDA?
Sbi Stafix (K071479) received a 510(k) decision of Substantially Equivalent on August 2, 2007, 65 days after the submission was received.
What is the product code of K071479?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.