Company ยท US
Macropore Biosurgery, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2004. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JEY | Plate, Bone | 3 |
| FTL | Mesh, Surgical, Polymeric | 2 |
| HRS | Plate, Fixation, Bone | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 |
| EZX | Mesh, Surgical, Metal | 1 |
| GXR | Cover, Burr Hole | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| MQN | External Mandibular Fixator And/Or Distractor | 1 |
| MTZ | Wrap, Implant, Orbital | 1 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 1 |
| OMH | Pericardial Patch To Facilitate Revision Surgeries | 1 |
| QPB | System, Suction, Lipoplasty For Removal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 20, 2004 | K042261 | MACROPORE PURICEL LIPOPLASTY SYSTEM Macropore Biosurgery, Inc. | QPB |
| Jul 28, 2004 | K041105 | MACROPORE HYDROSORB SPINE SYSTEM Macropore Biosurgery, Inc. | KWQ |
| Sep 22, 2003 | K031955 | MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET Macropore Biosurgery, Inc. | FTL |
| Sep 4, 2003 | K031785 | MACROPORE CARDIO-WRAP (TS) Macropore Biosurgery, Inc. | OMH |
| Jul 1, 2003 | K024169 | MACROPORE OS RECONSTRUCTION Macropore Biosurgery, Inc. | EZX |
| Feb 21, 2003 | K023643 | MACROPORE SURGICAL BARRIER FILM Macropore Biosurgery, Inc. | MTZ |
| Jul 1, 2002 | K021164 | MACROPORE OS TRAUMA Macropore Biosurgery, Inc. | HRS |
| Dec 3, 2001 | K012025 | MACROPORE SURGIWRAP (TS) Macropore Biosurgery, Inc. | FTL |
| Oct 25, 2001 | K012769 | MACROPORE ENT RECONSTRUCTION FILM Macropore Biosurgery, Inc. | NHB |
| Sep 18, 2001 | K012413 | MACROPORE FX, PS, NS, LP Macropore Biosurgery, Inc. | JEY |
| Aug 27, 2001 | K011715 | MACROPORE IB RESORBABLE PLUG Macropore Biosurgery, Inc. | JDI |
| Jul 20, 2001 | K010911 | MACROPORE OS SPINAL SYSTEM Macropore Biosurgery, Inc. | KWQ |
| Jul 11, 2001 | K002207 | MACROPOREPX PEDIATRIC SYSTEM Macropore Biosurgery, Inc. | JEY |
| May 2, 2001 | K002334 | MACROPORENS CRANILOC Macropore Biosurgery, Inc. | GXR |
| Oct 19, 2000 | K000696 | MACROPOREMX MANDIBULAR FIXATION SYSTEM Macropore Biosurgery, Inc. | JEY |
| Jul 24, 2000 | K994158 | MACROSORBOS PROTECTIVE SHEET Macropore Biosurgery, Inc. | HRS |
| Jun 26, 2000 | K000992 | MACROPOREDX DISTRACTOR SYSTEM Macropore Biosurgery, Inc. | MQN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||