Atlas FDA

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

OsteoCentric Technologies — Predicate Candidate Screening

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

54 daysmedian FDA review time
237 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies2025-08-16540
K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies2025-03-18260
K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies2024-10-09300
K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies2023-10-052480
K230226Integrity-SI® Fusion SystemOsteoCentric Technologies2023-09-212370
K230595OsteoCentric ACL Fixation SystemOsteoCentric Technologies2023-06-291180
K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies2023-04-18290
K222512Integrity-SI Fusion SystemOsteoCentric Technologies2022-09-12240
K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies2022-07-28800
K211290Cannulated Fasteners and NutsOsteoCentric Technologies2021-08-03970
K210754Cannulated Fasteners and NutsOsteoCentric Technologies2021-04-14300

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