EBI XFIX DFS RAIL SYSTEM— 510(k) K000083

Clearance details

Applicant

Ebi, L.P.

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2000-01-12

Decision date

2000-02-03

Decision

Substantially Equivalent

Clearance type

Special

Location

Parsippany, NJ, US

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• K253291 — Excelsior System2026-01-20
• K253202 — Hoffmann LRF System2025-12-19

• K100438 — POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM2010-06-23
• K100220 — POLARIS SPINAL SYSTEM2010-05-17
• K093880 — PEANUT GROWTH CONTROL PLATING SYSTEM2010-04-16
• K092574 — ESL SPINAL SYSTEM2010-02-04
• K093057 — BIOMET VISION FOOTRING SYSTEM2009-12-01

Death

11

Injury

3,097

Malfunction

1,261

Total

4,369

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 →

• Z-0527-2013 — EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.Class II·Terminated·Biomet, Inc.·20121109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K000083.