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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K113591

COLS PEEK · Fournitures Hospitalieres Industrie · decided 2011-12-22 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Chopping block256217FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489562174
CoLS Bone Tap250105FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489501050
Tendon hook265642FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489656422
CoLS retrograde reamer D11251831FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489518317
CoLS retrograde reamer D7253165FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489531651
Femoral ACL Universal guide255694FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489556944
Universal guide container256034FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489560347
CoLS upper tray V5264938FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489649387
BROCHE 23CM 2,4MM BOUT MECHE BOUT ROND (teknomedical)255994FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489559945
CoLS Open Tendon Stripper265664FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489656644
CoLS PCL femoral guide V5264929FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489649295
CoLS suture passer256010FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489560101
CoLS PCL tibial guide V5264928FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489649288
Stripper ouvert265644FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489656446
Universal guide double tunnel assembly255699FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489556999
Universal guide handle assembly255698FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489556982
BROCHE 25CM 2,4MM BOUT MECHE BOUT ROND (Teknomedical)257380FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489573804
CoLS Tape cutter razor blade265597FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489655975
CoLS ®266636 - CoLS® disposable instrumentsFOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489666360
CoLS Container V5264935FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489649356
Container256008FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489560088
CoLS workstation U-Handle lever assembly256012FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489560125
Wire for screw TLS D 1,8 LG 220mm255970FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489559709
Cannulated reamer Diameter 4,5251262FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489512629
CoLS workstation body256013FOURNITURES HOSPITALIERES INDUSTRIEHWC MBI03661489560132