FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMZ BONE TACK SYSTEM
K Number: K952167
·
Decision Nov 21, 1995
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
77
Applicant Total
25
Review Days
197
Basic Information
- Device Name
- IMZ BONE TACK SYSTEM
- K Number
- K952167
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- INTERPORE INTL.
- Date Received
- May 8, 1995
- Decision Date
- November 21, 1995
- Product Code
- DZL
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZL | Screw, Fixation, Intraosseous | FDA class 2 | Dental |
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|---|---|---|---|
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| K922732 | INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER | Feb 10, 1994 | Substantially Equivalent |