FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPEED SHIFT
K Number: K124022
·
Decision May 14, 2013
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
10
Review Days
137
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Basic Information
- Device Name
- SPEED SHIFT
- K Number
- K124022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomedical Enterprises, Inc.
- Date Received
- December 28, 2012
- Decision Date
- May 14, 2013
- Product Code
- JDR
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Biomedical Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K153573 | Converge | Aug 11, 2016 | Substantially Equivalent |
| K150125 | Elite Nitinol Fixation System | May 11, 2015 | Substantially Equivalent |
| K143023 | Nitinol Compression Plating System | Jan 16, 2015 | Substantially Equivalent |
| K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | Nov 17, 2014 | Substantially Equivalent |
| K133270 | SPEED ARC | Apr 17, 2014 | Substantially Equivalent |
| K133520 | HAMMERLOCK 2 | Jan 9, 2014 | Substantially Equivalent |
| K061385 | OSSTAPLE, OSSPLATE, OSSFORCE | May 30, 2007 | Substantially Equivalent |
| K023486 | OSSTAPLE, MAXILLOFACIAL | Oct 31, 2002 | Substantially Equivalent |
| K023488 | OSSTAPLE, CRANIOFACIAL | Oct 31, 2002 | Substantially Equivalent |