FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSTEM TEN MODEL 100 SURGICAL SYSTEM
K Number: K900003
·
Decision Mar 16, 1990
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
22
Applicant Total
2
Review Days
73
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Basic Information
- Device Name
- SYSTEM TEN MODEL 100 SURGICAL SYSTEM
- K Number
- K900003
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.4580
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Advanced Osseous Technologies
- Date Received
- January 2, 1990
- Decision Date
- March 16, 1990
- Product Code
- JDX
- 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 |
|---|---|---|---|
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | FDA class 2 | Orthopedic |
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Other Clearances by Advanced Osseous Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K905451 | SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE | Mar 5, 1991 | Substantially Equivalent |