FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
ARTHROBOT(TM) LOWER LIMB POSITIONER
K Number: K880227
·
Decision Feb 18, 1988
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
34
Applicant Total
16
Review Days
29
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Basic Information
- Device Name
- ARTHROBOT(TM) LOWER LIMB POSITIONER
- K Number
- K880227
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Andronic Devices, Ltd.
- Date Received
- January 20, 1988
- Decision Date
- February 18, 1988
- Product Code
- FQO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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|---|---|---|---|
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| K922625 | ADEPT ENDOSCOPIC POSITIONER | Oct 19, 1992 | Substantially Equivalent |
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| K911520 | ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE | Aug 2, 1991 | Substantially Equivalent |