Normed Medizin-Technik GmbH
FDA Regulatory Profile
Normed Medizin-Technik GmbH has 0 FDA recalls, 1 inspection, 9 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jan 31, 2013 · VAI
- Latest 510(k)
- Mar 2, 2016
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 9 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jan 31, 2013 | Tuttlingen, Germany | Devices | Voluntary Action Indicated (VAI) | 3003692365 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3003692365 | Tuttlingen, Germany | 1 | Jan 31, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K151708 | RECON system - Compression Screws | Mar 2, 2016 |
| K151701 | Tenodesis screw system | Jan 26, 2016 |
| K152256 | RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws | Nov 5, 2015 |
| K152312 | RECON system-V-TEK-IVP Plates and Screws | Oct 30, 2015 |
| K152142 | RECON system - MPJ-Plates | Sep 16, 2015 |
| K151407 | RECON system | Aug 12, 2015 |
| K133035 | NORMED PELLEGRIN CALCANEUS STOP SCREW | Dec 13, 2013 |
| K123347 | NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 | Aug 2, 2013 |
| K931539 | NORMED TITANIUM MINIPLATE SYSTEM | Jul 5, 1994 |