Atlas FDA

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

Pinnacle Spine Group, LLC — Predicate Candidate Screening

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

103 daysmedian FDA review time
133 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC2017-12-141330
K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC2015-11-191000
K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC2015-07-14710
K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC2015-04-03640
K143488InFill Graft Delivery SystemPinnacle Spine Group, LLC2014-12-1790
K140066INFILL CERVICALPinnacle Spine Group, LLC2014-05-051150
K133721INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOURPinnacle Spine Group, LLC2014-03-311160
K124012INFILL OBLIQUE TLIF DEVICEPinnacle Spine Group, LLC2013-06-041590
K121476INFILL GRAFT DELIVERY SYSTEMPinnacle Spine Group, LLC2012-08-291030
K121733INFILL INTERVERTEBRAL BODY FUSION DEVICEPinnacle Spine Group, LLC2012-07-13300
K111632INFILL GRAFT DELIVERY SYSTEMPinnacle Spine Group, LLC2011-08-11590
K103729INFILL INTERVERTEBRAL BODY FUSION DEVICEPinnacle Spine Group, LLC2011-04-181170

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