Company ยท US
Depuyacromed
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2004. Name variants (Inc, Corp, punctuation) are merged.
48510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 10 |
| MQP | Spinal Vertebral Body Replacement Device | 8 |
| MNI | Orthosis, Spinal Pedicle Fixation | 6 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 |
| LYC | Bone Grafting Material, Synthetic | 2 |
| FMF | Syringe, Piston | 1 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 1 |
| JEC | Component, Traction, Invasive | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2004 | K040197 | EAGLE ANTERIOR CERVIAL PLATE SYSTEM Depuyacromed | KWQ |
| Jun 23, 2003 | K031635 | DEPUY ACROMED VBR SYSTEM Depuyacromed | MQP |
| Apr 10, 2003 | K030833 | DEPUY ACROMED VBR SYSTEM Depuyacromed | MQP |
| Feb 26, 2003 | K030383 | MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS Depuyacromed | MNH |
| Feb 14, 2003 | K030249 | SURGICAL TITANIUM MESH SYSTEM Depuyacromed | MQP |
| Feb 5, 2003 | K030103 | SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS Depuyacromed | MNI |
| Jan 29, 2003 | K023835 | DEVEX MESH SYSTEM Depuyacromed | MQP |
| Jan 28, 2003 | K024348 | MONARCH SPINE SYSTEM Depuyacromed | MNH |
| Jan 23, 2003 | K023804 | MOSS MIAMI SPINAL SYSTEM PIN NUT Depuyacromed | KWP |
| Dec 11, 2002 | K021039 | BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM Depuyacromed | KWQ |
| Nov 13, 2002 | K023438 | MODIFICATION TO MONARCH SPINE SYSTEM Depuyacromed | MNH |
| Aug 27, 2002 | K022623 | 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) Depuyacromed | KWP |
| Aug 13, 2002 | K022285 | MODIFICATION TO ISOLA SPINAL SYSTEM Depuyacromed | MNI |
| Aug 2, 2002 | K022246 | MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM Depuyacromed | FMF |
| Jul 24, 2002 | K022190 | MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM Depuyacromed | MNI |
| Jul 11, 2002 | K021335 | MONARCH SPINE SYSTEM Depuyacromed | MNH |
| Jun 26, 2002 | K021880 | CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) Depuyacromed | MNH |
| Jun 26, 2002 | K021879 | CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) Depuyacromed | MNH |
| May 8, 2002 | K021148 | MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD Depuyacromed | MNH |
| Mar 21, 2002 | K020522 | MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM Depuyacromed | MQP |
| Mar 8, 2002 | K014053 | CONDUIT TCP GRANULES Depuyacromed | MQV |
| Nov 16, 2001 | K013441 | ISOLA POLYAXIAL WASHER Depuyacromed | KWP |
| Nov 16, 2001 | K012773 | DISCOVERY FACET SCREW FIXATION SYSTEM Depuyacromed | MRW |
| Nov 14, 2001 | K012738 | SYMPHONY GRAFT DELIVERY SYSTEM (GDS) Depuyacromed | GEY |
| Nov 7, 2001 | K013382 | MODIFICATION TO: STACKABLE CAGE SYSTEM Depuyacromed | MQP |
| Nov 7, 2001 | K013222 | SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM Depuyacromed | MNI |
| Oct 9, 2001 | K013296 | MOSS MIAMI SPINAL SYSTEMS Depuyacromed | MNH |
| Oct 9, 2001 | K013295 | TIMX SPINAL SYSTEMS Depuyacromed | MNH |
| Oct 9, 2001 | K013294 | MONARCH SPINAL SYSTEMS Depuyacromed | MNH |
| Oct 5, 2001 | K012971 | ISOLA SPINAL SYSTEMS Depuyacromed | MNH |
| Jul 18, 2001 | K010681 | SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM Depuyacromed | KWP |
| Jun 12, 2001 | K010972 | ISOLA BAND CLAMP Depuyacromed | MNI |
| May 23, 2001 | K010576 | MONARCH SPINE SYSTEM Depuyacromed | MNI |
| May 16, 2001 | K011182 | MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS Depuyacromed | MNH |
| May 8, 2001 | K003043 | SURGICAL TITANIUM MESH SYSTEM Depuyacromed | MQP |
| Apr 12, 2001 | K010742 | MOSS MIAMI 5.5MM TITANIUM PIN NUT Depuyacromed | MNH |
| Mar 1, 2001 | K010320 | MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM Depuyacromed | LYC |
| Jan 18, 2001 | K003286 | SYMPHONY GRAFT DELIVERY SYSTEM Depuyacromed | LYC |
| Jan 8, 2001 | K003822 | ISOLA CLOSED DUAL ROD CONNECTOR Depuyacromed | KWP |
| Dec 15, 2000 | K002733 | SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM Depuyacromed | KWP |
| Sep 12, 2000 | K002607 | MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS Depuyacromed | KWP |
| Aug 4, 2000 | K001470 | E-Z LINK CROSS CONNECTOR Depuyacromed | KWP |
| Jul 27, 2000 | K001372 | E-Z LINK CROSS CONNECTOR Depuyacromed | KWP |
| Jul 26, 2000 | K001340 | STACKABLE CAGE SYSTEM Depuyacromed | MQP |
| Apr 24, 2000 | K001105 | MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS Depuyacromed | KWP |
| Dec 29, 1999 | K993030 | MODIFICATION TO ISOLA SPINAL SYSTEM Depuyacromed | KWQ |
| Dec 15, 1999 | K993099 | BREMER HALO SYSTEM TITANIUM SKULL PIN Depuyacromed | JEC |
| Sep 23, 1999 | K992168 | MOSS MIAMI 6.35MM POLYAXIAL SCREW Depuyacromed | KWQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||