FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-WIRE
K Number: K903264
·
Decision Jul 30, 1990
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
200
Applicant Total
47
Review Days
6
Basic Information
- Device Name
- K-WIRE
- K Number
- K903264
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- ONYX MEDICAL CORP.
- Date Received
- July 24, 1990
- Decision Date
- July 30, 1990
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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Other Clearances by ONYX MEDICAL CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K942022 | FACE-IT SHIELD | Jul 8, 1994 | Substantially Equivalent |
| K931690 | SPOON PLATE | Jun 7, 1994 | Substantially Equivalent for Some Indications |
| K931692 | T-PLATE | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931680 | CANNULATED CANCELLOUS SCREW | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931684 | EPIPHYSIS PLATE | May 4, 1994 | Substantially Equivalent for Some Indications |
| K934614 | MINI FRAGMENT PLATE | May 4, 1994 | Substantially Equivalent for Some Indications |
| K934616 | CANCELLOUS BONE SCREW | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K931693 | 1/3 TUBULAR PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K931681 | CANNULATED NAVICULAR SCREW | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K931685 | FOREARM SELF COMPRESSION PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |