Company ยท IL
Disc-O-Tech Medical Technologies, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2007. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRX | Arthroscope | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 4 |
| NDN | Cement, Bone, Vertebroplasty | 4 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 2007 | K071375 | MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) Disc-O-Tech Medical Technologies, Ltd. | NDN |
| Dec 17, 2007 | K071679 | METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS Disc-O-Tech Medical Technologies, Ltd., IL | HSB |
| Nov 3, 2006 | K063067 | CONFIDENCE FENESTRATED INTRODUCER NEEDLE Disc-O-Tech Medical Technologies, Ltd. | NDN |
| Sep 14, 2006 | K062424 | CONFIDENCE EX HIGH VISCOSITY BONE CEMENT Disc-O-Tech Medical Technologies, Ltd. | NDN |
| Jun 21, 2006 | K060300 | CONFIDENCE HIGH VISCOSITY BONE CEMENT Disc-O-Tech Medical Technologies, Ltd., IL | NDN |
| Jun 17, 2004 | K040612 | SKY BONE EXPANDER SYSTEM (SKY SYSTEM) Disc-O-Tech Medical Technologies, Ltd., IL | HRX |
| May 12, 2004 | K040939 | SKY BONE EXPANDER SYSTEM (SKY SYSTEM) Disc-O-Tech Medical Technologies, Ltd., IL | HRX |
| Mar 26, 2004 | K032730 | FIXION HIP SYSTEM Disc-O-Tech Medical Technologies, Ltd., IL | JDI |
| Jan 28, 2004 | K034037 | SKY BONE EXPANDER SYSTEM Disc-O-Tech Medical Technologies, Ltd. | HRX |
| Dec 17, 2003 | K032358 | B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) Disc-O-Tech Medical Technologies, Ltd. | HRX |
| May 30, 2003 | K030972 | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) Disc-O-Tech Medical Technologies, Ltd., IL | KWL |
| Mar 8, 2002 | K014072 | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) Disc-O-Tech Medical Technologies, Ltd. | KWY |
| Dec 19, 2001 | K013449 | MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM Disc-O-Tech Medical Technologies, Ltd., IL | HSB |
| Jun 19, 2001 | K010988 | FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM Disc-O-Tech Medical Technologies, Ltd. | HSB |
| Jun 19, 2001 | K010901 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B Disc-O-Tech Medical Technologies, Ltd. | HSB |
| Jun 6, 2001 | K011390 | BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM Disc-O-Tech Medical Technologies, Ltd., IL | MBI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||