FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIXATION STAPLE KIT - DLIDE HAMMER
K Number: K834515
·
Decision Apr 23, 1984
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
5
Applicant Total
124
Review Days
124
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Basic Information
- Device Name
- FIXATION STAPLE KIT - DLIDE HAMMER
- K Number
- K834515
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Stryker Corp.
- Date Received
- December 21, 1983
- Decision Date
- April 23, 1984
- Product Code
- HXJ
- 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 |
|---|---|---|---|
| HXJ | Staple Driver | FDA class 1 | Orthopedic |
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