FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MALLEOLAR SCREW
K Number: K931686
·
Decision Apr 5, 1994
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
47
Review Days
365
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Basic Information
- Device Name
- MALLEOLAR SCREW
- K Number
- K931686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Onyx Medical Corp.
- Date Received
- April 5, 1993
- Decision Date
- April 5, 1994
- Product Code
- KTW
- 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 |
|---|---|---|---|
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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PK High Tibial Osteotomy Correction System
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ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
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AOS PROXIMAL HUMERAL PLATE
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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 |
| K934614 | MINI FRAGMENT PLATE | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931692 | T-PLATE | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931684 | EPIPHYSIS PLATE | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931680 | CANNULATED CANCELLOUS SCREW | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931679 | BUTTRESS PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K934615 | CANCELLOUS BONE SCREW | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K931683 | CLOVERLEAF PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K931693 | 1/3 TUBULAR PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |