Panels › Orthopedic › Product code KTT · Class 2
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation 888.3030
9510(k)s in 12 months (405 all time)
11recalls in 12 months (89 all time)
85recalls that name a 510(k)
Top companies in KTT
| Company | 510(k)s | Recalls |
|---|---|---|
| Ebi, L.P. | 36 | 2 |
| Synthes | 33 | 1 |
| Stryker Corp. | 11 | 15 |
| Orthofix Srl | 11 | 12 |
| Howmedica Corp. | 22 | 0 |
| Howmedica Osteonics Corp. | 19 | 1 |
| Zimmer, Inc. | 10 | 9 |
| Smith & Nephew | 16 | 0 |
| Wrightmedicaltechnologyinc | 11 | 0 |
| Alliance Medical Corp. | 9 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 28, 1982 | K823548 | COMPRESSION HIP SCREW SIDE-PLATE Howmedica Corp. | KTT |
| Jan 12, 1982 | K813554 | ACE/KYLE CAPTURED HIP SCREW Ace Orthopedic Manufacturing Co. | KTT |
| May 27, 1981 | K811017 | HUCKSTEP INTRAMEDULLARY NAIL Downs Surgical , Ltd. | KTT |
| Aug 28, 1979 | K791619 | DYNAMIC HIP SCREW Synthes (Usa) | KTT |
| Apr 10, 1979 | K790501 | PEDIATRIC OSTEOTOMY SYSTEM Howmedica Corp. | KTT |
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