FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEMONUCLEOLYSIS TABLE EXTENSION
K Number: K831042
·
Decision May 16, 1983
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
12
Applicant Total
95
Review Days
46
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CHEMONUCLEOLYSIS TABLE EXTENSION
- K Number
- K831042
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Orthopedic Systems, Inc.
- Date Received
- March 31, 1983
- Decision Date
- May 16, 1983
- Product Code
- FSE
- 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 |
|---|---|---|---|
| FSE | Table, Operating-Room, Manual | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSE), ordered by most recent decision date.
THE POREX RETRACTOR TABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MASON EQUIPMENT ORGANIZER & ASPEN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OPERATING ROOM STAND
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
IMSI/METRIPOND HAND OPERATING TABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SELF-CONTAINED MOBILE OPHTHAL. OPER. .
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TABLE, OPERATING, FIELD 6530-00-709-8155
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Orthopedic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952495 | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM | Jan 22, 1996 | Substantially Equivalent |
| K920256 | SPINE MOTION ANALYZER WITH EMG | Aug 10, 1992 | Substantially Equivalent |
| K910736 | JACKSON MULTIPURPOSE OPERATING TABLE | May 21, 1991 | Substantially Equivalent |
| K910031 | PARK CITY SHOULDER POSITIONER | Jan 24, 1991 | Substantially Equivalent |
| K903938 | C FIT CUP | Jan 4, 1991 | Substantially Equivalent for Some Indications |
| K892503 | NUFFIELD TOTAL KNEE | May 4, 1990 | Substantially Equivalent for Some Indications |
| K896678 | SILICONE PLUG | Jan 30, 1990 | Substantially Equivalent |
| K894283 | COMPREHENSIVE SPINE MOTION ANALYZER | Jan 19, 1990 | Substantially Equivalent |
| K890498 | FREEMAN MODULAR HIP STEM RIDGED VERSION | Oct 13, 1989 | Substantially Equivalent for Some Indications |
| K890331 | FREEMAN TOTAL HIP SYSTEM RIDGED STEM | Oct 13, 1989 | Substantially Equivalent |