Speed Shift
FDA 510(k) K124022 · Biomedical Enterprises, Inc.
510(k) numberK124022
Submission
- Device name
- Speed Shift
- Applicant
- Biomedical Enterprises, Inc.
San Antonio, TX, US - Received
- December 28, 2012
- Decision date
- May 14, 2013
- 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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| K061385 | Osstaple, Ossplate, OssforceKWQ · Traditional | 05/30/2007SE |
| K023488 | Osstaple, CraniofacialJEY · Special | 10/31/2002SE |
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Questions and answers
When was Speed Shift cleared by the FDA?
Speed Shift (K124022) received a 510(k) decision of Substantially Equivalent on May 14, 2013, 137 days after the submission was received.
What is the product code of K124022?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.