FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUTTER PROXIMAL INTERPHALANGEAL JOINT
K Number: K931588
·
Decision Mar 10, 1994
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
13
Applicant Total
7
Review Days
344
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Basic Information
- Device Name
- SUTTER PROXIMAL INTERPHALANGEAL JOINT
- K Number
- K931588
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3230
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sutter Corp.
- Date Received
- March 31, 1993
- Decision Date
- March 10, 1994
- Product Code
- KYJ
- 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 |
|---|---|---|---|
| KYJ | Prosthesis, Finger, Constrained, Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Sutter Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K943354 | SUTTER HAMMERTOE JOINT PROSTHESIS | Jun 12, 1995 | Substantially Equivalent |
| K945221 | SUTTER MODEL 6000 HAND CPM DEVICE | Feb 27, 1995 | Substantially Equivalent |
| K924654 | FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT | Feb 22, 1993 | Substantially Equivalent |
| K914860 | SUTTER MODEL 10000 LEG CPM DEVICE | Jan 8, 1992 | Substantially Equivalent |
| K902707 | MODEL 9000 AT ANKLE CPM DEVICE | Jul 25, 1990 | Substantially Equivalent |
| K890607 | SUTTER HOSPITAL CPM | Feb 27, 1989 | Substantially Equivalent |