FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TENSYN BAND
K Number: K133858
·
Decision Feb 28, 2014
Classifications
1
FEI Numbers
272
Registration Numbers
272
Same Product Code
92
Applicant Total
10
Review Days
71
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Basic Information
- Device Name
- TENSYN BAND
- K Number
- K133858
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dallen Medical, Inc.
- Date Received
- December 19, 2013
- Decision Date
- February 28, 2014
- Product Code
- HTN
- 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 |
|---|---|---|---|
| HTN | Washer, Bolt Nut | FDA class 2 | Orthopedic |
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Other Clearances by Dallen Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K171473 | Compressyn Staple | Nov 7, 2017 | Substantially Equivalent |
| K150359 | Tensyn Plug | May 7, 2015 | Substantially Equivalent |
| K143092 | Tensyn Plug | Feb 11, 2015 | Substantially Equivalent |
| K141264 | TENSYN BAND, TENSYN FRACTURE PLATES | Aug 21, 2014 | Substantially Equivalent |
| K140358 | COMPRESSYN STAPLE | Jun 2, 2014 | Substantially Equivalent |
| K132875 | COMPRESSYN STAPLE | Dec 30, 2013 | Substantially Equivalent |
| K131850 | TENSYN BAND | Nov 15, 2013 | Substantially Equivalent |
| K130431 | COMPRESSYN BAND | Jul 25, 2013 | Substantially Equivalent |
| K122871 | COMPRESSYN STAPLE | Feb 7, 2013 | Substantially Equivalent |