SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM— 510(k) K973836
Substantially Equivalent for Some IndicationsCross Medical Products, Inc.
FDA 510(k) clearance K973836 for SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM, Substantially Equivalent for Some Indications on 1998-03-05. Applicant: Cross Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Cross Medical Products, Inc.
- Product code
- Code MNH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Dublin, OH, US
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Adverse events under product code MNH
product code MNH- Injury
- 978
- Malfunction
- 793
- Total
- 1,771
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.