FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOSORB(R) ABSORBABLE PIN
K Number: K901456
·
Decision Aug 15, 1990
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
10
Review Days
141
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Basic Information
- Device Name
- ORTHOSORB(R) ABSORBABLE PIN
- K Number
- K901456
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson International
- Date Received
- March 27, 1990
- Decision Date
- August 15, 1990
- Product Code
- OVZ
- 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 |
|---|---|---|---|
| OVZ | Pin, Fixation, Resorbable, Hard Tissue | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OVZ), ordered by most recent decision date.
ORTHOSORB LS
FDA 510(k)
FDA Class 2
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ORTHOSORB RESORBABLE PINS
FDA 510(k)
FDA Class 2
·Orthopedic
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