FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLIVE K-WIRES
K Number: K903105
·
Decision Sep 6, 1990
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
84
Applicant Total
56
Review Days
63
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Basic Information
- Device Name
- OLIVE K-WIRES
- K Number
- K903105
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Danek Medical, Inc.
- Date Received
- July 5, 1990
- Decision Date
- September 6, 1990
- Product Code
- JEC
- 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 |
|---|---|---|---|
| JEC | Component, Traction, Invasive | FDA class 2 | Orthopedic |
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Other Clearances by Danek Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K994122 | BONE GRAFT WASHER, MODEL 9090114 - 9090118 | Feb 18, 2000 | Substantially Equivalent |
| K993810 | CD HORIZON SPINAL SYSTEM | Feb 3, 2000 | Substantially Equivalent |
| K993855 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM | Dec 15, 1999 | Substantially Equivalent |
| K991528 | MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR | May 28, 1999 | Substantially Equivalent |
| K990603 | MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM | Mar 10, 1999 | Substantially Equivalent |
| K982875 | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM | Jan 19, 1999 | Substantially Equivalent |
| K984522 | MODIFICATION OF TSRH SPINAL SYSTEM | Jan 6, 1999 | Substantially Equivalent |
| K982154 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM | Jul 13, 1998 | Substantially Equivalent |
| K970599 | TOWNLEY PEDICLE SCREW PLATING SYSTEM | Mar 20, 1998 | Substantially Equivalent |
| K943827 | SPINE FIXATION | Feb 14, 1996 | Substantially Equivalent for Some Indications |