CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM— 510(k) K940631

Substantially Equivalent for Some Indications

Cross Medical Products, Inc.

FDA 510(k) clearance K940631 for CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM, Substantially Equivalent for Some Indications on 1995-07-13. Applicant: Cross Medical Products, Inc..

Clearance details

Applicant: Cross Medical Products, Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1994-02-14
Decision date: 1995-07-13
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Concord, CA, 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, 2020-01-01 through 2026-04-23. 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.