SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS— 510(k) K974749

Substantially Equivalent for Some Indications

Cross Medical Products, Inc.

FDA 510(k) clearance K974749 for SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS, Substantially Equivalent for Some Indications on 1998-03-13. 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 →

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