Atlas FDA

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

G Surgical, LLC — Predicate Candidate Screening

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

31 daysmedian FDA review time
220 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K240737G Surgical Marksman MIS SystemG Surgical, LLC2024-04-05180
K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC2023-02-09310
K210890GPS Cervical SpacersG Surgical, LLC2021-04-23290
K193219G Surgical Marksman SystemG Surgical, LLC2019-12-17260
K171834G Surgical OCT Spinal SystemG Surgical, LLC2017-12-191820
K161516G Surgical Marksman MIS SystemG Surgical, LLC2016-08-25840
K142456GPS SpacersG Surgical, LLC2015-04-102200

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