510(k) K931682
- Device
- CANNULATED MALLEOLAR SCREW
- Applicant
- ONYX MEDICAL CORP.
- 510(k) number
- K931682
- Product code
- KWK
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1994-04-05
- Date received
- 1993-04-05
- Regulation
- 888.3030
- Classification name
- Appliance, Nail/blade/plate Combination, Single Component
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LARAINE B GILMORE
- Address
- 152 Collins St. Memphis TN US 38112 38112
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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