Atlas FDA

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

Fournitures Hospitalieres Industrie · Predicate Candidate Screening

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

111 daysmedian FDA review time
358 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie2018-01-232220
K163148BePOD® Foot ScrewsFournitures Hospitalieres Industrie2017-09-143090
K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie2017-09-082520
K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie2017-04-102580
K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie2017-04-04890
K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie2015-10-292370
K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie2015-05-22880
K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie2015-05-22880
K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie2015-03-201750
K120740COLS® FIXATION SYSTEMFournitures Hospitalieres Industrie2013-03-053580
K112193ARROW REVERSE SHOULDER SYSTEMFournitures Hospitalieres Industrie2012-07-123490
K113591COLS PEEKFournitures Hospitalieres Industrie2011-12-22170
K093599ARROW ANATOMICAL SHOULDER SYSTEMFournitures Hospitalieres Industrie2010-11-243690
K080974TLS FIXATION SYSTEMFournitures Hospitalieres Industrie2008-07-01880
K070617CANNULATED SCREWFournitures Hospitalieres Industrie2007-06-141010
K060367TENOLIGFournitures Hospitalieres Industrie2006-08-091770
K052058MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAILFournitures Hospitalieres Industrie2005-08-22240
K050556ALUMINA HEADFournitures Hospitalieres Industrie2005-05-11690
K042035ALUMINA HEADFournitures Hospitalieres Industrie2004-11-171110
K042332TITANIUM TELEGRAPH HUMERAL NAILFournitures Hospitalieres Industrie2004-10-07380
K041456SNAP-OFF SCREWSFournitures Hospitalieres Industrie2004-08-25850
K031939BIO-EUROLIG INTERFERENCE SCREWFournitures Hospitalieres Industrie2004-06-243670
K033510MODIFICATION TO TELEGRAPH HUMERAL NAILFournitures Hospitalieres Industrie2003-12-03270
K023241TELEGRAPH HUMERAL NAILFournitures Hospitalieres Industrie2002-12-24850

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