FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
K Number: K131635
·
Decision Aug 29, 2013
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
5
Review Days
86
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Basic Information
- Device Name
- ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
- K Number
- K131635
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rotation Medical, Inc.
- Date Received
- June 4, 2013
- Decision Date
- August 29, 2013
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Rotation Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140300 | COLLAGEN TENDON SHEET-DDI (CTS-DDI) | Mar 26, 2014 | Substantially Equivalent |
| K131637 | ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) | Jul 12, 2013 | Substantially Equivalent |
| K122048 | COLLAGEN TENDON SHEET-D | Jan 8, 2013 | Substantially Equivalent |
| K112423 | COLLAGEN TENDON SHEET | Dec 22, 2011 | Substantially Equivalent |