Atlas FDA

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

Back 2 Basics Direct, LLC — Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC2020-05-122080
K191537eCarbon IBDsBack 2 Basics Direct, LLC2019-09-261080
K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC2017-05-22490
K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC2015-06-151390

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