ClearanceBrief
510(k) K150818 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System

ApplicantZimmer, Inc., Warsaw IN, US
DecisionSubstantially Equivalent, May 1, 2015
ReceivedMar 27, 2015
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K150818

DateFirm and productCodeLinked 510(k)
Oct 10, 2019Zimmer Biomet, Inc.
Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 0011
Terminated		 KTTNone listed
May 16, 2016Zimmer Manufacturing B.V.
VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
Terminated		 KTTNone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRESSION SCREW 1-1/2IN 47116202200 COMPRESSION SCREW 1-1/4IN 47
Terminated		 KTTNone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 118114
Terminated		 KTTNone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 12.7D X 105MM STA 119301047 LAG SCR 12.7D X 110MM STA 119301
Terminated		 KTTNone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEYLESS SHORT 119413596 VERSA-FX II KEYLESS SHORT 1194130
Terminated		 KTTNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.