Atlas FDA

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

Ulrich GmbH & Co. KG · Predicate Candidate Screening

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

182 daysmedian FDA review time
269 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (Ulrich GmbH & Co. KG2025-11-181190
K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG2025-11-071960
K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (Ulrich GmbH & Co. KG2024-08-26600
K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (Ulrich GmbH & Co. KG2024-04-191490
K210541ulrichINJECT CT motionUlrich GmbH & Co. KG2021-08-061630
K202227Artus™ cervical plate systemUlrich GmbH & Co. KG2020-09-14380
K192872ulrichINJECT CT MotionUlrich GmbH & Co. KG2020-07-022680
K192117Small VBR™Ulrich GmbH & Co. KG2019-11-01870
K171392ulrichINJECT CT motionUlrich GmbH & Co. KG2017-11-091820
K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG2016-12-222530
K161723ulrich Transfer SetUlrich GmbH & Co. KG2016-12-211820
K150650neon3Ulrich GmbH & Co. KG2015-09-241960
K122957TEZO TITANIUM CAGE FAMILYUlrich GmbH & Co. KG2013-06-212690
K123717UCENTUMUlrich GmbH & Co. KG2013-03-04900
K120891TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEMUlrich GmbH & Co. KG2012-10-011920
K113346NEON SYSTEMUlrich GmbH & Co. KG2012-02-281060
K103814PEZO INTERBODY CAGES SYSTEMUlrich GmbH & Co. KG2011-03-17780
K101353GOLDEN GATE ANTERIOR PLATE SYSTEMUlrich GmbH & Co. KG2011-02-042660
K102853FLAMENCO SPINAL FIXATION SYSTEMUlrich GmbH & Co. KG2011-01-251180
K090861MAMBO, MODEL CS 18XX-XXUlrich GmbH & Co. KG2010-05-214170
K090841ADDPLUSUlrich GmbH & Co. KG2009-10-051920
K080841COSMIC SYSTEMUlrich GmbH & Co. KG2008-07-231190
K060416OBELISC VERTEBRAL BODY REPLACEMENT DEVICEUlrich GmbH & Co. KG2006-12-263120
K052385TANGORS POLYAXIAL SYSTEMUlrich GmbH & Co. KG2005-12-271190

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