SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II— 510(k) K973586

Substantially Equivalent for Some Indications

Spinal Concepts, Inc.

FDA 510(k) clearance K973586 for SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II, Substantially Equivalent for Some Indications on 1997-11-07. Applicant: Spinal Concepts, Inc..

Clearance details

Applicant: Spinal Concepts, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1997-09-22
Decision date: 1997-11-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.