Macropore Biosurgery, Inc.: FDA clearances and approvals
Macropore Biosurgery, Inc. has 17 FDA 510(k) clearances (first 2000, latest 2004), across 12 product codes in 7 review panels. Median 510(k) review time: 90 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JEY | Plate, Bone | 3 | 3 |
| FTL | Mesh, Surgical, Polymeric | 2 | 2 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| EZX | Mesh, Surgical, Metal | 1 | 1 |
| GXR | Cover, Burr Hole | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| MQN | External Mandibular Fixator And/Or Distractor | 1 | 1 |
| MTZ | Wrap, Implant, Orbital | 1 | 1 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 1 | 1 |
Plus 2 more product codes.
Review panels
- Orthopedic (5)
- Dental (4)
- General and Plastic Surgery (4)
- Cardiovascular (1)
- Ear, Nose and Throat (1)
- Neurology (1)
- Ophthalmic (1)
Most recent Macropore Biosurgery, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042261 | MACROPORE PURICEL LIPOPLASTY SYSTEM | QPB | 2004-09-20 | 28 |
| K041105 | MACROPORE HYDROSORB SPINE SYSTEM | KWQ | 2004-07-28 | 89 |
| K031955 | MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET | FTL | 2003-09-22 | 89 |
| K031785 | MACROPORE CARDIO-WRAP (TS) | OMH | 2003-09-04 | 86 |
| K024169 | MACROPORE OS RECONSTRUCTION | EZX | 2003-07-01 | 195 |
| K023643 | MACROPORE SURGICAL BARRIER FILM | MTZ | 2003-02-21 | 114 |
| K021164 | MACROPORE OS TRAUMA | HRS | 2002-07-01 | 81 |
| K012025 | MACROPORE SURGIWRAP (TS) | FTL | 2001-12-03 | 158 |
| K012769 | MACROPORE ENT RECONSTRUCTION FILM | NHB | 2001-10-25 | 69 |
| K012413 | MACROPORE FX, PS, NS, LP | JEY | 2001-09-18 | 50 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Macropore Biosurgery, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Macropore Biosurgery, Inc. have?
Macropore Biosurgery, Inc. has 17 FDA 510(k) clearances (first 2000, latest 2004), across 12 product codes in 7 review panels.
How long does FDA take to clear Macropore Biosurgery, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Macropore Biosurgery, Inc.'s cleared 510(k)s is 90 days.
What devices does Macropore Biosurgery, Inc. make?
Its most frequent FDA product codes are JEY (Plate, Bone, 3); FTL (Mesh, Surgical, Polymeric, 2); HRS (Plate, Fixation, Bone, 2).
Has Macropore Biosurgery, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Macropore Biosurgery, Inc. Related entities may recall under other names.
Next steps
- See all 17 Macropore Biosurgery, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JEY, Macropore Biosurgery, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.