Company ยท US
Theken Surgical,Llc
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2005. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2005 | K050058 | THEKEN REVEAL VBR SYSTEM Theken Surgical,Llc | MQP |
| Sep 16, 2004 | K041592 | CORAL SPINAL SYSTEM Theken Surgical | KWP |
| Feb 20, 2004 | K032064 | THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM Theken Surgical,Llc | MQP |
| Oct 29, 2001 | K012462 | THEKEN LARGE CEMENT RESTRICTOR Theken Surgical,Llc | JDK |
| Oct 17, 2001 | K012278 | THEKEN SMALL CEMENT RESTRICTOR Theken Surgical,Llc | JDK |
| May 16, 2001 | K010466 | TETHER ACFS Theken Surgical,Llc | KWQ |
| Mar 10, 2000 | K994382 | NONLINEAR TAPER LAG SCREW Theken Surgical | HWC |
| Feb 4, 2000 | K994383 | DOGBONE ACFS Theken Surgical | KWQ |
| Dec 30, 1998 | K983622 | BODYFORM THORACO-LUMBAR FIXATION SYSTEM Theken Surgical,Llc | KWQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||