Company ยท US
Sofamor Danek USA,Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2000. Name variants (Inc, Corp, punctuation) are merged.
43510(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 | 13 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 7 |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 |
| HRX | Arthroscope | 4 |
| GWG | Endoscope, Neurological | 1 |
| HRS | Plate, Fixation, Bone | 1 |
| JEY | Plate, Bone | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 10, 2000 | K991031 | COLORADO II SPINAL SYSTEM Sofamor Danek USA,Inc. | MNH |
| Mar 30, 2000 | K984360 | COLORADO II SPINAL SYSTEM Sofamor Danek USA,Inc. | MNH |
| Sep 21, 1999 | K992928 | CD HORIZON SPINAL SYSTEM Sofamor Danek USA,Inc. | MNI |
| Sep 14, 1999 | K992110 | PREMIER ANTERIOR CERVICAL PLATE SYSTEM Sofamor Danek USA | KWQ |
| Sep 14, 1999 | K991036 | DANEK PLATE AND SCREW SYSTEM Sofamor Danek USA,Inc. | MNH |
| Aug 27, 1999 | K991198 | DYNA-LOK PLUS SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| May 19, 1999 | K991460 | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM Sofamor Danek | MNH |
| May 19, 1999 | K991364 | MODIFICATION TO TENOR SPINAL SYSTEM-PLATES Sofamor Danek USA,Inc. | MNH |
| Jan 28, 1999 | K981676 | CD HORIZON SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Dec 18, 1998 | K980184 | CD SPINAL SYSTEM Sofamor Danek USA,Inc. | MNI |
| Dec 16, 1998 | K983672 | DYNA-LOK SPINAL SYSTEM Sofamor Danek USA,Inc. | MNI |
| Nov 12, 1998 | K983706 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM Sofamor Danek USA,Inc. | KWP |
| Oct 21, 1998 | K982990 | TSRH SPINAL SYSTEM Sofamor Danek USA,Inc. | MNI |
| Oct 5, 1998 | K982490 | TENOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Aug 7, 1998 | K982686 | MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM Sofamor Danek USA,Inc. | MNI |
| Mar 18, 1998 | K963642 | INCL II ENDOSCOPE Sofamor Danek USA,Inc. | GWG |
| Mar 16, 1998 | K973854 | ORION ANTERIOR CERVICAL PLATE SYSTEM Sofamor Danek USA,Inc. | KWQ |
| Jan 16, 1998 | K974017 | TIMESH SYSTEM Sofamor Danek USA,Inc. | HRS |
| Nov 19, 1997 | K973145 | TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM Sofamor Danek USA,Inc. | JEY |
| Oct 16, 1997 | K964159 | CD SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Jul 30, 1997 | K963780 | DUAL ROD ANTERIOR FIXATOR SYSTEM Sofamor Danek USA,Inc. | KWQ |
| May 2, 1997 | K970806 | ACPII ANTERIOR CERVICAL PLATE SYSTEM Sofamor Danek USA,Inc. | KWQ |
| Apr 21, 1997 | K964254 | TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Mar 17, 1997 | K965193 | LIBERTY ANTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWQ |
| Feb 28, 1997 | K953076 | TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM Sofamor Danek USA,Inc. | MRW |
| Feb 6, 1997 | K964623 | TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWQ |
| Feb 6, 1997 | K962708 | TITANIUM CD HORIZON SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Jan 14, 1997 | K964275 | ALPHA POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Dec 5, 1996 | K961633 | CD HORIZON SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Nov 27, 1996 | K963655 | CD HORIZON ANTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWQ |
| Oct 1, 1996 | K955807 | COTREL-DUBOUSSET (CD) SPINAL Sofamor Danek USA,Inc. | KWP |
| Mar 27, 1996 | K955365 | COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Feb 14, 1996 | K950717 | AUGMENT-T POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | MNH |
| Feb 9, 1996 | K951164 | CD LIBERTY POSTERIOR SPINCAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Jan 16, 1996 | K954645 | TITANIUM GDLH POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Dec 18, 1995 | K955471 | INCL ENDOSCOPE Sofamor Danek USA,Inc. | HRX |
| Nov 21, 1995 | K946087 | INCLUSICE II(TM) ENDOSCOPE Sofamor Danek USA,Inc. | HRX |
| Oct 30, 1995 | K953635 | TITANIUM DYNA-LOK SPINAL SYSTEM Sofamor Danek USA,Inc. | MNH |
| Aug 28, 1995 | K950596 | GDLH POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | MNH |
| Aug 25, 1995 | K950955 | PARAGON POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | MNH |
| Aug 7, 1995 | K946348 | TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) Sofamor Danek USA,Inc. | MNH |
| May 12, 1995 | K950501 | DANEK RIGID ARTHROSCOPE Sofamor Danek USA,Inc. | HRX |
| May 1, 1995 | K950130 | MICRO-ENDO(TM) INSTRUMENTS Sofamor Danek USA,Inc. | HRX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||