Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Cross Medical Products, Inc. · Predicate Candidate Screening

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

148 daysmedian FDA review time
514 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K974749SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROCross Medical Products, Inc.1998-03-13840
K973836SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF Cross Medical Products, Inc.1998-03-051480
K950709SYNERGY TI ANTERIOR SPINAL SYSTEMCross Medical Products, Inc.1995-10-252540
K940631CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEMCross Medical Products, Inc.1995-07-135140
K924381PWB LUMBAR LAMINAR HOOKS WITH SET SCREWSCross Medical Products, Inc.1993-05-182600
K920116PWB LUMBOSACRAL SPINE SYSTEMCross Medical Products, Inc.1992-04-10880
K895587CROSS MEDICAL PRODUCT PEDICLE AWLCross Medical Products, Inc.1990-01-041110

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