ClearanceBrief
510(k) K830196 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

CORSTREN COMPRESSION TUBE & PLATE

ApplicantZimmer, Inc., Mchenry IL, US
DecisionSubstantially Equivalent, Mar 25, 1983
ReceivedJan 20, 1983
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K830196

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
Apr 28, 2017Zimmer Biomet, Inc.
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
Terminated
KTTNone listed
Apr 28, 2017Zimmer Biomet, Inc.
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
Terminated
KTTNone listed
Apr 28, 2017Zimmer Biomet, Inc.
4.5 BROAD SCP PLT 26-H STER
Terminated
KTTNone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100
Terminated
KTTNone listed
Aug 26, 2014Zimmer, Inc.
Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE
Terminated
HRSNone listed
Feb 20, 2014Zimmer, Inc.
FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.
Terminated
KTTNone listed
Aug 26, 2013Zimmer, Inc.
Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER
Terminated
KTTNone listed
Aug 26, 2013Zimmer, Inc.
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with
Terminated
KTTNone listed
Aug 26, 2013Zimmer, Inc.
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with
Terminated
KTTNone listed
Aug 26, 2013Zimmer, Inc.
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 a
Terminated
KTTNone listed
Aug 26, 2013Zimmer, Inc.
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 an
Terminated
KTTNone listed

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