510(k) K132594 · HRS Plate, Fixation, Bone

CROSSCHECK PLATING SYSTEM

Applicant	Solana Surgical, LLC, Memphis TN, US
Decision	Substantially Equivalent, Dec 13, 2013
Received	Aug 19, 2013
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K132594

Date	Firm and product	Code	Linked 510(k)
Sep 1, 2015	Wright Medical Technology, Inc. CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm Terminated	HRS	None listed
Sep 1, 2015	Wright Medical Technology, Inc. CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3.0 x 14 mm, REF CCP-N3014l; 3.0 x 16 mm, REF CCP-N3016; 3.0 x 1 Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthopedic use. Terminated	HRS	None listed
Apr 22, 2015	Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use. Terminated	HRS	None listed

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