Arthrotek, Inc.
Warsaw, IN, US
Arthrotek, Inc. appears in FDA device records in Warsaw, IN. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Arthrotek, Inc. between 1987 and 2006. The busiest year on record is 2004, with 6. The most recent is 2006, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 6 |
| 2005 | 1 |
| 2006 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K061776 | ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE | JDR | Substantially Equivalent | |
| K061801 | 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS | JDR | Substantially Equivalent | |
| K061657 | HITCH LACTOSORB SUTURE ANCHOR | JDR | Substantially Equivalent | |
| K061389 | ALLTHREAD LACTOSORB SUTURE ANCHOR | JDR | Substantially Equivalent | |
| K060693 | MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR | HWC | Substantially Equivalent | |
| K053461 | EZLOC FEMORAL FIXATION DEVICE | MBI | Substantially Equivalent | |
| K051069 | NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER | MBI | Substantially Equivalent | |
| K042460 | TI - SCREW ANCHOR SP | MBI | Substantially Equivalent | |
| K041274 | RESORBABLE INTERFERENCE SCREW | HWC | Substantially Equivalent | |
| K041261 | FEMORAL HOOK | MBI | Substantially Equivalent | |
| K040604 | INNERVUE DIAGNOSTIC SCOPE SYSTEM | GCJ | Substantially Equivalent | |
| K040500 | ARTHROTEK LACTONAIL | HTY | Substantially Equivalent | |
| K033718 | MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE | GAT | Substantially Equivalent | |
| K032072 | LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE | HWC | Substantially Equivalent | |
| K014305 | RESORBABLE LACTOSORB-L ACL CROSSPIN | HTY | Substantially Equivalent | |
| K012872 | RESORBABLE SCREW ANCHOR | HWC | Substantially Equivalent | |
| K862286 | ARTHROPHONOMETER | NFQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain