DJ ORTHOPEDICS TIBIAL ANCHOR— 510(k) K003960

Name: FDA 510(k) clearance K003960
Creator: U.S. Food and Drug Administration
Published: 2001-03-21

Substantially Equivalent

Dj Orthopedics, LLC

FDA 510(k) clearance K003960 for DJ ORTHOPEDICS TIBIAL ANCHOR, Substantially Equivalent on 2001-03-21. Applicant: Dj Orthopedics, LLC. Device class: 2.

Clearance details

Applicant: Dj Orthopedics, LLC
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2000-12-21
Decision date: 2001-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Dj Orthopedics, LLC

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K021740 — TOTAL KNEE CEMENTED, SEMI-CONSTRAINED2002-09-23
K011354 — HIGH TIBIAL OSTEOTOMY PLATING SYSTEM2001-07-31
K010594 — DJ ORTHOPEDICS POST SCREW2001-05-29
K010595 — DJ ORTHOPEDICS INTERFERENCE SCREW2001-05-08
K002829 — DJ ORTHOPEDICS FEMORAL ANCHOR2001-03-26

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.