Atlas FDA

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

Eit Emerging Implant Technologies GmbH · Predicate Candidate Screening

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

85 daysmedian FDA review time
140 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium AEit Emerging Implant Technologies GmbH2020-07-15300
K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019-02-04540
K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018-10-121120
K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular TitaniumEit Emerging Implant Technologies GmbH2017-12-15850
K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PEit Emerging Implant Technologies GmbH2017-07-111400

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