FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MITEK CUFFTACK
K Number: K003076
·
Decision Oct 27, 2000
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
30
Review Days
24
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Basic Information
- Device Name
- MITEK CUFFTACK
- K Number
- K003076
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mitek Products
- Date Received
- October 3, 2000
- Decision Date
- October 27, 2000
- Product Code
- MAI
- 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 |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Mitek Products
| K Number | Device Name | ||
|---|---|---|---|
| K013572 | MITEK BIOCRYL INTERFERENCE SCREWS | Mar 14, 2002 | Substantially Equivalent |
| K013781 | RIDIDFIX 2.7MM BTB CROSS PIN KIT | Feb 6, 2002 | Substantially Equivalent |
| K002639 | BIOKNOTLESS ANCHOR | May 11, 2001 | Substantially Equivalent |
| K010633 | RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM | May 9, 2001 | Substantially Equivalent |
| K002406 | MITEK 2GII MENISCAL REPAIR SYSTEM | Feb 15, 2001 | Substantially Equivalent |
| K002402 | VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM | Aug 31, 2000 | Substantially Equivalent |
| K002422 | VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM | Aug 31, 2000 | Substantially Equivalent |
| K000936 | VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM | Apr 19, 2000 | Substantially Equivalent |
| K993575 | RESOLVE QUICKANCHOR | Dec 29, 1999 | Substantially Equivalent |
| K993327 | TALON ANCHOR SNAP-PAK | Dec 16, 1999 | Substantially Equivalent |