Panels › Orthopedic › Product code HXS · Class 1
Twister, Wire
Regulation 888.4540
0510(k)s in 12 months (2 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in HXS
| Company | 510(k)s | Recalls |
|---|---|---|
| KARDIUM INC. | 0 | 2 |
| Bionic Instrument Corp. | 1 | 0 |
| Orthopedic Equipment Co., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2012 | Kardium TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A.
The Catalog numbers are:
17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, Terminated |
HXS | None listed |
| Jul 9, 2010 | KARDIUM INC. TORQ Sternal Closure Device, SINGLE-USE
Intended use: The device is a sterile, single-use only surgical instrument used to tension and twist USP size 5, 6, and 7 (metric size 7.0, 8.0, and 9.0) sta Terminated |
HXS | None listed |
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