ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES— 510(k) K933112

Name: FDA 510(k) clearance K933112
Creator: U.S. Food and Drug Administration
Published: 1994-02-17

Substantially Equivalent

Alphatec Mfg., Inc.

FDA 510(k) clearance K933112 for ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES, Substantially Equivalent on 1994-02-17. Applicant: Alphatec Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Alphatec Mfg., Inc.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1993-06-25
Decision date: 1994-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Desert, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

More clearances from Alphatec Mfg., Inc.

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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 HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.