SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM— 510(k) K974525

Substantially Equivalent for Some Indications

Synthes Spine

FDA 510(k) clearance K974525 for SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM, Substantially Equivalent for Some Indications on 1998-03-02. Applicant: Synthes Spine.

Clearance details

Applicant: Synthes Spine
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1997-12-02
Decision date: 1998-03-02
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.