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

Newdeal Sas · Predicate Candidate Screening

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

44 daysmedian FDA review time

478 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K103623	NEWDEAL INTERPHALANGEAL IMPLANT	Newdeal Sas	2012-03-20	466	0
K093914	NEWDEAL COMPRESSION PLATES	Newdeal Sas	2011-04-14	478	5
K093781	MODIFIED: NEWDEAL HALLU PLATES	Newdeal Sas	2010-01-22	44	0
K091788	PANTA NAIL (DIA. 10MM), PANTA NAIL XL	Newdeal Sas	2009-07-29	42	1
K083154	NEWDEAL HALLU LOCK PLATE SYSTEM	Newdeal Sas	2009-07-10	259	1
K091609	NEWDEAL COMPRESSION PLATE	Newdeal Sas	2009-06-30	27	1
K073375	NEWDEAL TIBIAXYS SYSTEM	Newdeal Sas	2008-02-21	80	1
K071639	QWIX POSITIONING SCREW	Newdeal Sas	2007-07-09	24	0
K070447	NEWDEAL COMPRESSION PLATE	Newdeal Sas	2007-03-29	42	2
K063831	BASAL DORSAL PLATES	Newdeal Sas	2007-02-07	43	0

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