Atlas FDA

CROSSCHECK PLATING SYSTEM

FDA 510(k) clearance K132594 · decided 2013-12-13

Clearance details

K-number
K132594
Device name
CROSSCHECK PLATING SYSTEM
Applicant
Solana Surgical, LLC
Decision
Substantially Equivalent
Date received
2013-08-19
Decision date
2013-12-13
Days to decision
116 days
Clearance type
Traditional
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, R recall (Z-2541-2015)Wright Medical Technology, Inc.2015-09-01
CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 m recall (Z-2542-2015)Wright Medical Technology, Inc.2015-09-01
CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use. recall (Z-1482-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use. recall (Z-1483-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L. Orthopedic u recall (Z-1484-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic recall (Z-1485-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic recall (Z-1486-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R. Orthopedic recall (Z-1487-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic recall (Z-1488-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R. Orthopedic recall (Z-1489-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use. recall (Z-1490-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use. recall (Z-1491-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use. recall (Z-1492-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use. recall (Z-1493-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use. recall (Z-1494-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use. recall (Z-1495-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use. recall (Z-1496-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use. recall (Z-1497-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use. recall (Z-1498-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthopedic use. recall (Z-1499-2015)Wright Medical Technology, Inc.2015-04-22
CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use. recall (Z-1500-2015)Wright Medical Technology, Inc.2015-04-22