Normed Medizin-Technik GmbH
Austin, TX, US
Normed Medizin-Technik GmbH appears in FDA device records in Austin, TX. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Normed Medizin-Technik GmbH between 1994 and 2016. The busiest year on record is 2015, with 4. The most recent is 2016, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 2013 | 2 |
| 2015 | 4 |
| 2016 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151708 | RECON system - Compression Screws | HWC | Substantially Equivalent | |
| K151701 | Tenodesis screw system | HWC | Substantially Equivalent | |
| K152256 | RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws | HRS | Substantially Equivalent | |
| K152312 | RECON system-V-TEK-IVP Plates and Screws | HRS | Substantially Equivalent | |
| K152142 | RECON system - MPJ-Plates | HRS | Substantially Equivalent | |
| K151407 | RECON system | HRS | Substantially Equivalent | |
| K133035 | NORMED PELLEGRIN CALCANEUS STOP SCREW | HWC | Substantially Equivalent | |
| K123347 | NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 | HRS | Substantially Equivalent | |
| K931539 | NORMED TITANIUM MINIPLATE SYSTEM | JEY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain