Normed Medizin-Technik GmbH: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Normed Medizin-Technik GmbH” (first 1994, latest 2016), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 87 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 | 2 | 176 |
| 2014 | 0 | — |
| 2015 | 4 | 76 |
| 2016 | 2 | 234 |
| 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 5 | 5 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| JEY | Plate, Bone | 1 | 1 |
Review panels
- Orthopedic (8)
- Dental (1)
Most recent Normed Medizin-Technik GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151708 | RECON system - Compression Screws | HWC | 2016-03-02 | 252 |
| K151701 | Tenodesis screw system | HWC | 2016-01-26 | 216 |
| K152256 | RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws | HRS | 2015-11-05 | 87 |
| K152312 | RECON system-V-TEK-IVP Plates and Screws | HRS | 2015-10-30 | 74 |
| K152142 | RECON system - MPJ-Plates | HRS | 2015-09-16 | 44 |
| K151407 | RECON system | HRS | 2015-08-12 | 78 |
| K133035 | NORMED PELLEGRIN CALCANEUS STOP SCREW | HWC | 2013-12-13 | 77 |
| K123347 | NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 | HRS | 2013-08-02 | 275 |
| K931539 | NORMED TITANIUM MINIPLATE SYSTEM | JEY | 1994-07-05 | 463 |
Recalls
openFDA lists no recalls under a recalling firm named Normed Medizin-Technik GmbH.
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.
- Normed Nedizin Technik GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Normed Medizin-Technik GmbH?
FDA lists 9 510(k) clearances under the applicant name “Normed Medizin-Technik GmbH” (first 1994, latest 2016), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Normed Medizin-Technik GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Normed Medizin-Technik GmbH is 87 days.
Which FDA product codes appear under Normed Medizin-Technik GmbH?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 5); HWC (Screw, Fixation, Bone, 3); JEY (Plate, Bone, 1).
Next steps
- See all 9 Normed Medizin-Technik GmbH clearances with predicates and recalls
- Run predicate analysis for product code HRS, Normed Medizin-Technik 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.