FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TALON ANCHOR SNAP-PAK
K Number: K993261
·
Decision Dec 2, 1999
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
30
Review Days
64
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Basic Information
- Device Name
- TALON ANCHOR SNAP-PAK
- K Number
- K993261
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mitek Products
- Date Received
- September 29, 1999
- Decision Date
- December 2, 1999
- 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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|---|---|---|---|
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| K002406 | MITEK 2GII MENISCAL REPAIR SYSTEM | Feb 15, 2001 | Substantially Equivalent |
| K003076 | MITEK CUFFTACK | Oct 27, 2000 | 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 |