FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANSPACH SUTURE ANCHOR
K Number: K965069
·
Decision Feb 12, 1997
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
60
Review Days
61
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Basic Information
- Device Name
- ANSPACH SUTURE ANCHOR
- K Number
- K965069
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Anspach Effort, Inc.
- Date Received
- December 13, 1996
- Decision Date
- February 12, 1997
- 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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