Merete Medical GmbH: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Merete Medical GmbH” (first 2005, latest 2016), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 84 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 | 2 | 144 |
| 2013 | 3 | 45 |
| 2014 | 2 | 131 |
| 2015 | 2 | 171 |
| 2016 | 2 | 126 |
| 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 7 | 7 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 5 | 5 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 4 | 4 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| JDW | Pin, Fixation, Threaded | 2 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 2 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | 1 | 1 |
Review panels
- Orthopedic (25)
Most recent Merete Medical GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160548 | MC-Subtalar(TM) II | HWC | 2016-04-29 | 60 |
| K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws | HWC | 2016-02-12 | 191 |
| K151762 | PediatrOS RigidTack/FlexTack | JDR | 2015-12-28 | 182 |
| K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System | HSB | 2015-02-09 | 160 |
| K141377 | BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD | LZO | 2014-11-21 | 178 |
| K140069 | LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 | HRS | 2014-04-07 | 84 |
| K132226 | METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT | HRS | 2013-08-09 | 23 |
| K123619 | INTRABLOCK BIOBALL HIP SYSTEM (IBS) | LZO | 2013-05-24 | 182 |
| K130400 | MERETEC CS, CORTICAL SCREWS | HWC | 2013-04-05 | 45 |
| K120787 | MERETE LOCKING BONE PLATE SYSTEM III | HRS | 2012-11-27 | 257 |
15 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2022-01-18.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Merete GmbH (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Merete Medical GmbH?
FDA lists 25 510(k) clearances under the applicant name “Merete Medical GmbH” (first 2005, latest 2016), across 8 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 Merete Medical GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Merete Medical GmbH is 84 days.
Which FDA product codes appear under Merete Medical GmbH?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 7); HSB (Rod, Fixation, Intramedullary And Accessories, 5); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 4).
Next steps
- See all 25 Merete Medical GmbH clearances with predicates and recalls
- Run predicate analysis for product code HWC, Merete Medical GmbH'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.