SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM— 510(k) K980928

Substantially Equivalent

Synthes Spine

FDA 510(k) clearance K980928 for SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM, Substantially Equivalent on 1998-05-11. Applicant: Synthes Spine.

Clearance details

Applicant: Synthes Spine
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1998-03-11
Decision date: 1998-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.