ALPHA SPINAL SYSTEM— 510(k) K930515

Name: FDA 510(k) clearance K930515
Creator: U.S. Food and Drug Administration
Published: 1994-06-29

Unknown

Alphatec Mfg., Inc.

FDA 510(k) clearance K930515 for ALPHA SPINAL SYSTEM, Unknown on 1994-06-29. Applicant: Alphatec Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Alphatec Mfg., Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
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 ↗

Recent devices under product code KWP

view all

K143278 — LnK Posterior Cervical Fixation System2015-07-29
K150753 — OASYS System2015-06-09
K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System2015-06-04
K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

More clearances from Alphatec Mfg., Inc.

view all

K033090 — ICON POLYAXIAL PEDICLE SCREW SYSTEM2004-03-26
K023299 — ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM2002-12-11
K020356 — ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM2002-07-23
K993513 — DELTALOC ANTERIOR CERVICAL PLATE SYSTEM2000-04-26
K993873 — ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD2000-01-03

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.