Intelifuse, Inc.
Yorba Linda, CA, US
Intelifuse, Inc. appears in FDA device records in Yorba Linda, CA. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Intelifuse, Inc. between 2005 and 2006. The busiest year on record is 2005, with 1. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1033-2009 | InteliFUSE, Drill Bit, 2.00 mm, J-Latch, QTY: 1, REF: DB.200.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, LA 70112, MDCI Arundel House, 1 Liverpool Gardens, Worthing, West Sussex BN11 1SL, United Kingdom Intended Use: Creating of holes for implant placement. | Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings. | Terminated | ||
| Z-1032-2009 | InteliFUSE, Drill Bit, 1.50 mm, J-Latch, QTY: 1, REF: DB.150.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, LA 70112, MDCI Arundel House, 1 Liverpool Gardens, Worthing, West Sussex BN11 1SL, United Kingdom Intended Use: Creating of holes for implant placement. | Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain