Atlas FDA

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

Spirit Ridge Technologies · Predicate Candidate Screening

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

75 daysmedian FDA review time
75 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952707SILICONE ELASTOMER MALAR IMPLANTSpirit Ridge Technologies1995-08-28750
K952709PROTHESIS, CHIN, INTERNALSpirit Ridge Technologies1995-08-28750
K952706SPIRIT RIDGE SILICONE CARVING BLOCKSpirit Ridge Technologies1995-08-28750
K952708PECTORALIS IMPLANTSpirit Ridge Technologies1995-08-28750
K952705SPIRIT RIDGE NASAL IMPLANTSpirit Ridge Technologies1995-08-28750

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