FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TYPE 316L STAINLESS STEEL WIRE
K Number: K880309
·
Decision Feb 29, 1988
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
11
Review Days
35
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Basic Information
- Device Name
- TYPE 316L STAINLESS STEEL WIRE
- K Number
- K880309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Winn Hirsch & Assoc.
- Date Received
- January 25, 1988
- Decision Date
- February 29, 1988
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Winn Hirsch & Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K864375 | TYPE 316L COTTER WIRE | May 20, 1987 | Substantially Equivalent for Some Indications |
| K832213 | GAUZE CONVERSION CLASS II STERILE | Jul 26, 1983 | Substantially Equivalent |
| K832214 | GAUZE CONVERSION CLASS I-NON-STERILE | Jul 26, 1983 | Substantially Equivalent |
| K830511 | ZANLEX, ZAN-TEX & ZANDEX | Mar 17, 1983 | Substantially Equivalent |
| K812391 | NEUROSPONGES | Nov 24, 1981 | Substantially Equivalent |
| K812390 | NEUROSPONGE PADDIE | Nov 24, 1981 | Substantially Equivalent |
| K800195 | COTTON UNDER CAST PADDING | Feb 11, 1980 | Substantially Equivalent |
| K761155 | CELLULOSE EYE STICK | Dec 16, 1976 | Substantially Equivalent |
| K760513 | ELECTRODE, TEMPORARY MYOCARDIAL | Oct 15, 1976 | Substantially Equivalent |
| K760365 | BLANKET, BURN | Aug 11, 1976 | Substantially Equivalent |