MYKRES SPINAL SYSTEM— 510(k) K051704
Substantially EquivalentShowa Ika Kohgyo Co., Ltd.
FDA 510(k) clearance K051704 for MYKRES SPINAL SYSTEM, Substantially Equivalent on 2006-07-03. Applicant: Showa Ika Kohgyo Co., Ltd..
Clearance details
- Applicant
- Showa Ika Kohgyo Co., Ltd.
- Product code
- Code MNI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego,, CA, US
Adverse events under product code MNI
product code MNI- Injury
- 641
- Total
- 641
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.