Atlas FDA

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

Rsb Spine, LLC — Predicate Candidate Screening

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

77 daysmedian FDA review time
161 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K092540C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMARsb Spine, LLC2010-01-271610
K092070INTERPLATE CRsb Spine, LLC2009-10-06900
K081194INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)Rsb Spine, LLC2008-05-29310
K071922INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGCRsb Spine, LLC2007-09-18680
K071372MODIFICATION TO: INTERPLATE VBR SYSTEMRsb Spine, LLC2007-06-11260
K070316INTERPLATE VBR SYSTEMRsb Spine, LLC2007-04-19770
K061401INTERPLATE VBR SYSTEMRsb Spine, LLC2006-08-18910

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