EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS— 510(k) K992367

Name: FDA 510(k) clearance K992367
Creator: U.S. Food and Drug Administration
Published: 1999-09-23

Substantially Equivalent

Electro-Biology, Inc.

FDA 510(k) clearance K992367 for EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS, Substantially Equivalent on 1999-09-23. Applicant: Electro-Biology, Inc.. Device class: 2.

Clearance details

Applicant: Electro-Biology, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1999-07-15
Decision date: 1999-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Electro-Biology, Inc.

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K992333 — EBI OMEGA 21 SYSTEM1999-10-08
K991941 — EBI XFIX DFS RAIL SYSTEM1999-08-19
K990303 — EBI OMEGA 21 SYSTEM1999-04-29
K991092 — EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM1999-04-29
K990459 — EBI VUECATH ENDOSCOPIC SYSTEN1999-04-23

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 →

Recalls naming K992367

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992367.

Data sourced from openFDA. This site is unofficial and independent of the FDA.