AME UNIVERSAL FIXATION SYSTEM — American Medical Electronics, Inc. (510(k) K931381)
AME UNIVERSAL FIXATION SYSTEM — American Medical Electronics, Inc. (510(k) K931381) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: AME UNIVERSAL FIXATION SYSTEM; Applicant: American Medical Electronics, Inc.; Clearance track: 510(k).
| Device name | AME UNIVERSAL FIXATION SYSTEM |
|---|---|
| Applicant | American Medical Electronics, Inc. |
| Clearance track | 510(k) |
| Submission number | K931381 |
| Decision | Substantially Equivalent for Some Indications |
| Decision date | 1995-02-01 |
| Date received | 1993-03-18 |
| Product code | KWP |
| Device class | 2 |
| Medical specialty | Orthopedic |
| Applicant location | TX, US |
| Source | openFDA device |
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$1999/mo
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