FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO
K Number: K897141
·
Decision Jun 21, 1990
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
5
Applicant Total
5
Review Days
176
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Basic Information
- Device Name
- SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO
- K Number
- K897141
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Stuart
- Date Received
- December 27, 1989
- Decision Date
- June 21, 1990
- Product Code
- JDN
- 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 |
|---|---|---|---|
| JDN | Implant, Fixation Device, Spinal | FDA class 2 | Orthopedic |
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