Memometal Technologies: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Memometal Technologies” (first 2007, latest 2011), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 106 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | 3 | 3 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
Review panels
- Orthopedic (10)
Most recent Memometal Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112197 | MEMOMETAL INTRA-MEDULLARY BONE FASTENER | HTY | 2011-11-17 | 108 |
| K101930 | MEMOMETAL NAVIS BONE PLATING SYSTEM | HRS | 2011-03-15 | 249 |
| K102072 | MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) | HTY | 2010-11-03 | 103 |
| K093820 | SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | HWC | 2010-05-19 | 156 |
| K083447 | MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50 | HRS | 2009-02-06 | 77 |
| K071941 | MEMOMETAL BONE ANCHORS | HWC | 2007-12-04 | 144 |
| K070598 | MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE | HTY | 2007-07-26 | 146 |
| K070039 | MEMOMETAL FIXOS SCREWS | HWC | 2007-03-21 | 77 |
| K070033 | MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10 | JDR | 2007-03-19 | 75 |
| K070031 | MEMOMETAL MEMORY STAPLES | JDR | 2007-03-19 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named Memometal Technologies.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Memometal Technologies?
FDA lists 10 510(k) clearances under the applicant name “Memometal Technologies” (first 2007, latest 2011), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Memometal Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Memometal Technologies is 106 days.
Which FDA product codes appear under Memometal Technologies?
The most frequent FDA product codes under this applicant name are HTY (Pin, Fixation, Smooth, 3); HWC (Screw, Fixation, Bone, 3); HRS (Plate, Fixation, Bone, 2).
Next steps
- See all 10 Memometal Technologies clearances with predicates and recalls
- Run predicate analysis for product code HTY, Memometal Technologies's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.