FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUTTER LESSER METATARSAL CAP
K Number: K861983
·
Decision Sep 8, 1986
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
11
Review Days
109
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Basic Information
- Device Name
- SUTTER LESSER METATARSAL CAP
- K Number
- K861983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3730
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Sutter Biomedical, Inc.
- Date Received
- May 22, 1986
- Decision Date
- September 8, 1986
- Product Code
- KWD
- 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 |
|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | FDA class 2 | Orthopedic |
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Other Clearances by Sutter Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K875249 | SUTTER PHALANGEAL CAP | Feb 3, 1988 | Substantially Equivalent |
| K870200 | SUTTER FINGER JOINT PROSTHESIS | Oct 9, 1987 | Substantially Equivalent |
| K850274 | SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT | Apr 25, 1985 | Substantially Equivalent |
| K830974 | SUTTER CPM 5000 | Apr 12, 1983 | Substantially Equivalent |
| K830649 | SUTTER CPM 2000 | Mar 17, 1983 | Substantially Equivalent |
| K823539 | SUTTER CPM | Jan 14, 1983 | Substantially Equivalent |
| K820813 | LESSER METATARSAL PHALANG. JOINT PROSTH | May 21, 1982 | Substantially Equivalent |
| K820083 | SUTTER CPM | Jan 28, 1982 | Substantially Equivalent |
| K812691 | SILICONE IMPLANTS | Nov 16, 1981 | Substantially Equivalent |
| K802342 | PROXIMAL INTERPHALANGEAL JOINT IMPLANT | Oct 14, 1981 | Substantially Equivalent |