Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Normed Medizin-Technik GmbH · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

87 daysmedian FDA review time
463 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH2016-03-022520
K151701Tenodesis screw systemNormed Medizin-Technik GmbH2016-01-262160
K152256RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis PlNormed Medizin-Technik GmbH2015-11-05870
K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH2015-10-30740
K152142RECON system - MPJ-PlatesNormed Medizin-Technik GmbH2015-09-16440
K151407RECON systemNormed Medizin-Technik GmbH2015-08-12780
K133035NORMED PELLEGRIN CALCANEUS STOP SCREWNormed Medizin-Technik GmbH2013-12-13770
K123347NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEMNormed Medizin-Technik GmbH2013-08-022750
K931539NORMED TITANIUM MINIPLATE SYSTEMNormed Medizin-Technik GmbH1994-07-054630

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda