Atlas FDA

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

Double Medical Technology, Inc. — Predicate Candidate Screening

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

257 daysmedian FDA review time
340 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252729Universal Spinal SystemDouble Medical Technology, Inc.2025-11-18820
K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.2024-12-041180
K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.2023-11-22580
K223753Cervical Plate SystemDouble Medical Technology, Inc.2023-03-14900
K221150Advanced Bone PlateDouble Medical Technology, Inc.2023-01-252800
K221088Anatomic Bone PlateDouble Medical Technology, Inc.2023-01-182800
K221090Metal Cannulated ScrewDouble Medical Technology, Inc.2023-01-102720
K221221Advanced Intramedullary Nail SystemDouble Medical Technology, Inc.2022-12-212380
K220921Metal Bone ScrewDouble Medical Technology, Inc.2022-12-122570
K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.2018-08-243400
K172828Double Medical Cage SystemDouble Medical Technology, Inc.2018-02-011360
K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.2016-08-224480

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