Atlas FDA

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

Choicespine, LP — Predicate Candidate Screening

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

102 daysmedian FDA review time
175 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP2019-05-01850
K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP2019-03-06890
K182721Choice Spine Navigation SystemChoicespine, LP2019-01-081020
K183214Raven Lumbar Plate SystemChoicespine, LP2019-01-03450
K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP2018-05-16780
K172816TiGer Shark™ SystemChoicespine, LP2018-01-261300
K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP2018-01-191090
K171489Acapella Cervical Spacer SystemChoicespine, LP2017-10-231540
K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook FixaChoicespine, LP2017-06-08800
K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open PedicleChoicespine, LP2017-04-26270
K170953Tomcat Cervical Spinal SystemChoicespine, LP2017-04-21210
K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Choicespine, LP2016-11-231170
K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle ScrChoicespine, LP2016-06-03740
K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Choicespine, LP2016-05-192050
K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015-12-181070
K140142CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARChoicespine, LP2014-07-161750
K133214BLACKBIRD SPINAL SYSTEMChoicespine, LP2014-03-071400
K121850Typhoon(TM) Facet Screw Fixation SystemChoicespine, LP2012-09-20870
K120570CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEMChoicespine, LP2012-04-05380
K102204CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEMChoicespine, LP2010-11-151020
K091926CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEMChoicespine, LP2009-12-221750
K073669ORIA NATURA SPACERChoicespine, LP2008-02-13490

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