FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
TYPE 316L COTTER WIRE
K Number: K864375
·
Decision May 20, 1987
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
7
Applicant Total
11
Review Days
196
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Basic Information
- Device Name
- TYPE 316L COTTER WIRE
- K Number
- K864375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Winn Hirsch & Assoc.
- Date Received
- November 5, 1986
- Decision Date
- May 20, 1987
- Product Code
- LRN
- 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 |
|---|---|---|---|
| LRN | Wire, Surgical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRN), ordered by most recent decision date.
NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
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STAINLESS STEEL SOFT SUTURE WIRE
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J-FX CERCLAGE SYSTEM
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OXBORO-MEDICAL PIN COVERS
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ORTHOPAEDIC WIRES
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FDA Class 2
·Orthopedic
TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Winn Hirsch & Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K880309 | TYPE 316L STAINLESS STEEL WIRE | Feb 29, 1988 | Substantially Equivalent |
| 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 |