ALPHA SPINAL SYSTEM— 510(k) K930515

Unknown

Alphatec Mfg., Inc.

FDA 510(k) clearance K930515 for ALPHA SPINAL SYSTEM, Unknown on 1994-06-29. Applicant: Alphatec Mfg., Inc..

Clearance details

Applicant: Alphatec Mfg., Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1993-02-01
Decision date: 1994-06-29
Decision: Unknown
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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.