FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTITAK SS
K Number: K993115
·
Decision Dec 17, 1999
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
12
Review Days
88
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Basic Information
- Device Name
- MULTITAK SS
- K Number
- K993115
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bonutti Research, Inc.
- Date Received
- September 20, 1999
- Decision Date
- December 17, 1999
- 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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| K090175 | UNITY BETA PLLA SYSTEM | Sep 10, 2009 | Substantially Equivalent |
| K082906 | UNITY BETA ANCHOR SYSTEM | Oct 30, 2008 | Substantially Equivalent |
| K062820 | UNITY ALPHA SYSTEM | Mar 15, 2007 | Substantially Equivalent |
| K060283 | TRANSET SYSTEM | Feb 22, 2006 | Substantially Equivalent |
| K052799 | MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM | Dec 16, 2005 | Substantially Equivalent |
| K033717 | TRANSET FRACTURE FIXATION SYSTEM | Feb 25, 2004 | Substantially Equivalent |
| K013177 | MULTITAK SUTURE SNAP SYSTEM | Dec 19, 2001 | Substantially Equivalent |
| K012465 | MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR | Oct 29, 2001 | Substantially Equivalent |