Company ยท US
Danek Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2000. Name variants (Inc, Corp, punctuation) are merged.
56510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 16 |
| HRX | Arthroscope | 5 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 |
| MNI | Orthosis, Spinal Pedicle Fixation | 3 |
| ILI | Sling, Arm | 2 |
| JDQ | Cerclage, Fixation | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 |
| FNJ | Bed, Manual | 1 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 |
| HOQ | Grid, Amsler | 1 |
| HST | Apparatus, Traction, Non-Powered | 1 |
| HTN | Washer, Bolt Nut | 1 |
| ILE | Sling, Arm, Overhead Supported | 1 |
| IME | Pack, Hot Or Cold, Reusable | 1 |
| IOD | Components, Exercise | 1 |
| IOZ | Splint, Abduction, Congenital Hip Dislocation | 1 |
| IPX | Orthosis, Rib Fracture, Soft | 1 |
| IPY | Orthosis, Lumbo-Sacral | 1 |
| IQI | Orthosis, Limb Brace | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 18, 2000 | K994122 | BONE GRAFT WASHER, MODEL 9090114 - 9090118 Danek Medical, Inc. | KWQ |
| Feb 3, 2000 | K993810 | CD HORIZON SPINAL SYSTEM Danek Medical, Inc. | MNH |
| Dec 15, 1999 | K993855 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM Danek Medical, Inc. | KWQ |
| May 28, 1999 | K991528 | MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR Danek Medical, Inc. | MNH |
| Mar 10, 1999 | K990603 | MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM Danek Medical, Inc. | KWQ |
| Jan 19, 1999 | K982875 | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM Danek Medical, Inc. | KWQ |
| Jan 6, 1999 | K984522 | MODIFICATION OF TSRH SPINAL SYSTEM Danek Medical, Inc. | MNI |
| Jul 13, 1998 | K982154 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM Danek Medical, Inc. | MNI |
| Mar 20, 1998 | K970599 | TOWNLEY PEDICLE SCREW PLATING SYSTEM Danek Medical, Inc. | MNI |
| Feb 14, 1996 | K943827 | SPINE FIXATION Danek Medical, Inc. | MNH |
| May 10, 1995 | K943356 | INCLUSIVE ENDOSCOPE Danek Medical, Inc. | HRX |
| Nov 21, 1994 | K943676 | DANEKSCOPE OPTI-PROBE Danek Medical, Inc. | HRX |
| May 4, 1994 | K933205 | TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON Danek Medical, Inc. | KWP |
| Jan 28, 1994 | K933242 | SOFAMOR ORTHOPAEDIC INSTRUMENTS Danek Medical, Inc. | LXH |
| Apr 5, 1993 | K911729 | DANEKSCOPE AND ACCESSORIES Danek Medical, Inc. | HRX |
| Feb 14, 1992 | K901692 | DANEK SPINALSCOPE Danek Medical, Inc. | HRX |
| Jan 22, 1992 | K904243 | TSRH VARIABLE ANGLE SACRAL SCREW Danek Medical, Inc. | KWP |
| Nov 18, 1991 | K913735 | SONGER(TM) CABLE SYSTEM Danek Medical, Inc. | JDQ |
| Oct 25, 1991 | K904520 | RAY SACRAL FIXATION SYSTEM Danek Medical, Inc. | KWP |
| Oct 24, 1991 | K911307 | CROSSLINK PLATE Danek Medical, Inc. | KWP |
| Sep 11, 1991 | K911379 | DANEK SACRAL HOOK, MODIFICATION Danek Medical, Inc. | KWP |
| Sep 10, 1991 | K911306 | T-BOLT AND NUT Danek Medical, Inc. | HTN |
| Sep 6, 1991 | K911319 | TSRH OPEN HEAD BONE SCREW Danek Medical, Inc. | KWP |
| Apr 5, 1991 | K911300 | MICROSURGICAL INSTRUMENTS Danek Medical, Inc. | HRX |
| Dec 10, 1990 | K902775 | KNIGHT SACRAL SCREW Danek Medical, Inc. | KWP |
| Dec 10, 1990 | K901005 | TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) Danek Medical, Inc. | KWP |
| Dec 5, 1990 | K903461 | TSRH OFFSET AND SIDE-LOADING HOOKS Danek Medical, Inc. | KWP |
| Nov 5, 1990 | K901587 | TSRH SACRAL L-CONNECTOR Danek Medical, Inc. | KWP |
| Sep 10, 1990 | K903676 | STERNOTOMY CABLE, SONGER CABLE SYSTEM Danek Medical, Inc. | JDQ |
| Sep 6, 1990 | K903105 | OLIVE K-WIRES Danek Medical, Inc. | JEC |
| Aug 21, 1990 | K901590 | DANEK SACRAL HOOK Danek Medical, Inc. | KWP |
| Aug 9, 1990 | K895978 | CHIBA SPINAL SYSTEM Danek Medical, Inc. | KWP |
| Jun 14, 1990 | K896254 | DANEK PRECISION ROD SET Danek Medical, Inc. | KWP |
| Feb 26, 1990 | K896740 | AXIAL AND OFFSET CROSSLINK PLATES Danek Medical, Inc. | KWP |
| Jan 30, 1990 | K896603 | HSC UNIT ROD Danek Medical, Inc. | KWP |
| Jan 4, 1990 | K890192 | LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET Danek Medical, Inc. | KWP |
| Aug 28, 1989 | K891066 | DANEK WRIST FIXATOR Danek Medical, Inc. | KTT |
| Jul 25, 1989 | K892651 | SONGER WIRING SYSTEM Danek Medical, Inc. | LRN |
| Jun 13, 1989 | K890814 | DANEK RING FIXATOR (DRF) Danek Medical, Inc. | KTT |
| Jan 24, 1989 | K890090 | DANEK IRRIGATING BURR (DIB) SET Danek Medical, Inc. | GFF |
| Jul 22, 1985 | K843227 | MACULAR FUNCTION ANALYZER Danek Medical, Inc. | HOQ |
| Jan 21, 1983 | K823821 | SIDE RAIL PADS Danek Medical, Inc. | FNJ |
| Jan 14, 1983 | K823823 | LUMBOSACRAL SUPPORT Danek Medical, Inc. | IPY |
| Jan 14, 1983 | K823822 | ANKLE WEIGHTS Danek Medical, Inc. | IOD |
| Jan 14, 1983 | K823820 | ABDUCTION PILLOW Danek Medical, Inc. | IOZ |
| Jan 14, 1983 | K823819 | CAST TOE COVER Danek Medical, Inc. | LGF |
| Jan 14, 1983 | K823816 | WHEELCHAIR PATIENT RESTRAINTS Danek Medical, Inc. | KNO |
| Jan 14, 1983 | K823814 | HOT/COLD PACK HOLDERS Danek Medical, Inc. | IME |
| Jan 14, 1983 | K823813 | TRACTION ACCESSORIES Danek Medical, Inc. | HST |
| Jan 14, 1983 | K823812 | VARIOUS SUPPORTS AND SPLINTS Danek Medical, Inc. | IQI |
Newest 50 of 56.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||