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Cols® Fixation System

by Fournitures Hospitalieres Industrie

510(k) K120740

Cols® Fixation System is a Class II device made by Fournitures Hospitalieres Industrie, cleared under FDA 510(k) K120740 on 5 Mar 2013, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK120740 Date5 Mar 2013ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MBI
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K120740

70 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K120740
UDI-DISize and differences
BROCHE 25CM 2,4MM BOUT MECHE BOUT ROND (Teknomedical) 257380
FOURNITURES HOSPITALIERES INDUSTRIE
25738003661489573804
Single use: no
On the market
Chopping block 256217
FOURNITURES HOSPITALIERES INDUSTRIE
25621703661489562174
Single use: no
On the market
CoLS 2.4mm guide pin Lg 250mm Soft/drill 264586
FOURNITURES HOSPITALIERES INDUSTRIE
26458603661489645860
Single use: no
On the market
CoLS ACL femoral point to point guide V2 265072
FOURNITURES HOSPITALIERES INDUSTRIE
26507203661489650727
Single use: no
On the market
CoLS ACL tibial point to point guide V2 264927
FOURNITURES HOSPITALIERES INDUSTRIE
26492703661489649271
Single use: no
On the market
CoLS Bone Tap 250105
FOURNITURES HOSPITALIERES INDUSTRIE
25010503661489501050
Single use: no
On the market
CoLS long cannula 264933
FOURNITURES HOSPITALIERES INDUSTRIE
26493303661489649332
Single use: no
On the market
CoLS long cannula driver 264934
FOURNITURES HOSPITALIERES INDUSTRIE
26493403661489649349
Single use: no
On the market
CoLS Open Tendon Stripper 265664
FOURNITURES HOSPITALIERES INDUSTRIE
26566403661489656644
Single use: no
On the market
CoLS PCL femoral guide V5 264929
FOURNITURES HOSPITALIERES INDUSTRIE
26492903661489649295
Single use: no
On the market
CoLS PCL tibial guide V5 264928
FOURNITURES HOSPITALIERES INDUSTRIE
26492803661489649288
Single use: no
On the market
CoLS PCL Tray 266843
FOURNITURES HOSPITALIERES INDUSTRIE
26684303661489668432
Single use: no
On the market
CoLS PCL Tray Lid 266844
FOURNITURES HOSPITALIERES INDUSTRIE
26684403661489668449
Single use: no
On the market
CoLS PEEK 3,5mm screwdriver cannula 1,8mm 263783
FOURNITURES HOSPITALIERES INDUSTRIE
26378303661489637834
Single use: no
On the market
CoLS retrograde reamer D10 250101
FOURNITURES HOSPITALIERES INDUSTRIE
25010103661489501012
Single use: no
On the market
CoLS retrograde reamer D7 253165
FOURNITURES HOSPITALIERES INDUSTRIE
25316503661489531651
Single use: no
On the market
CoLS retrograde reamer D8 251830
FOURNITURES HOSPITALIERES INDUSTRIE
25183003661489518300
Single use: no
On the market
CoLS retrograde reamer D9 250102
FOURNITURES HOSPITALIERES INDUSTRIE
25010203661489501029
Single use: no
On the market
CoLS suture passer 256010
FOURNITURES HOSPITALIERES INDUSTRIE
25601003661489560101
Single use: no
On the market
CoLS Tape cutter 264932
FOURNITURES HOSPITALIERES INDUSTRIE
26493203661489649325
Single use: no
On the market
CoLS Tape cutter razor blade 265597
FOURNITURES HOSPITALIERES INDUSTRIE
26559703661489655975
Single use: no
On the market
CoLS universal guide drilling sleeve V5 264939
FOURNITURES HOSPITALIERES INDUSTRIE
26493903661489649394
Single use: no
On the market
CoLS universal guide handle V5 264930
FOURNITURES HOSPITALIERES INDUSTRIE
26493003661489649301
Single use: no
On the market
CoLS upper tray V5 264938
FOURNITURES HOSPITALIERES INDUSTRIE
26493803661489649387
Single use: no
On the market
CoLS workstation body 256013
FOURNITURES HOSPITALIERES INDUSTRIE
25601303661489560132
Single use: no
On the market
CoLS workstation brass nut assembly 256011
FOURNITURES HOSPITALIERES INDUSTRIE
25601103661489560118
Single use: no
On the market
CoLS workstation U-Handle lever assembly 256012
FOURNITURES HOSPITALIERES INDUSTRIE
25601203661489560125
Single use: no
On the market
CoLS ®
FOURNITURES HOSPITALIERES INDUSTRIE
266637 - CoLS® 2.4 mm disposable guide pin03661489666377
Single use: yes
On the market
CoLS ®
FOURNITURES HOSPITALIERES INDUSTRIE
266639 - CoLS® 1.8mm disposable screw pin03661489666391
Single use: yes
On the market
CoLS ® 266638 - CoLS® 4.5mm disposable drill
FOURNITURES HOSPITALIERES INDUSTRIE
266638 - CoLS® 4.5mm disposable drill03661489666384
Single use: yes
On the market
COLS® 266136 - CoLS TITANIUM SCREW, Ø10 L20
FOURNITURES HOSPITALIERES INDUSTRIE
266136 - CoLS TITANIUM SCREW, Ø10 L2003661489661365
Single use: yes
On the market
COLS® 266142 - TAPES AND BLADE, Qty2
FOURNITURES HOSPITALIERES INDUSTRIE
266142 - TAPES AND BLADE, Qty203661489661426
Single use: yes
On the market
Container 256008
FOURNITURES HOSPITALIERES INDUSTRIE
25600803661489560088
Single use: no
On the market
Container TLS V8 268225
FOURNITURES HOSPITALIERES INDUSTRIE
26822503661489682254
Single use: no
On the market
Femoral ACL Universal guide 255694
FOURNITURES HOSPITALIERES INDUSTRIE
25569403661489556944
Single use: no
On the market
Femoral guide offset 6mm 264936
FOURNITURES HOSPITALIERES INDUSTRIE
26493603661489649363
Single use: no
On the market
masselotte tournevis PEEK 266864
FOURNITURES HOSPITALIERES INDUSTRIE
26686403661489668647
Single use: no
On the market
Open stripper 242049
FOURNITURES HOSPITALIERES INDUSTRIE
24204903661489420498
Single use: no
On the market
PCL wire catcher 264931
FOURNITURES HOSPITALIERES INDUSTRIE
26493103661489649318
Single use: no
On the market
Plaque longueur de greffe TLS 267267
FOURNITURES HOSPITALIERES INDUSTRIE
26726703661489672675
Single use: no
On the market
Stripper ouvert 265644
FOURNITURES HOSPITALIERES INDUSTRIE
26564403661489656446
Single use: no
On the market
Tendon hook 265642
FOURNITURES HOSPITALIERES INDUSTRIE
26564203661489656422
Single use: no
On the market
Tibial guide in the elbow 264940
FOURNITURES HOSPITALIERES INDUSTRIE
26494003661489649400
Single use: no
On the market
Tibial PCL Universal guide 255697
FOURNITURES HOSPITALIERES INDUSTRIE
25569703661489556975
Single use: no
On the market
TLS LCP additional tray 266149
FOURNITURES HOSPITALIERES INDUSTRIE
26614903661489661495
Single use: no
On the market
TLS workstation 264937
FOURNITURES HOSPITALIERES INDUSTRIE
26493703661489649370
Single use: no
On the market
Universal drilling handle 255693
FOURNITURES HOSPITALIERES INDUSTRIE
25569303661489556937
Single use: no
On the market
Universal guide double tunnel assembly 255699
FOURNITURES HOSPITALIERES INDUSTRIE
25569903661489556999
Single use: no
On the market
Universal guide handle assembly 255698
FOURNITURES HOSPITALIERES INDUSTRIE
25569803661489556982
Single use: no
On the market
Wire for screw TLS D 1,8 LG 220mm 255970
FOURNITURES HOSPITALIERES INDUSTRIE
25597003661489559709
Single use: no
On the market

Similar devices

Other devices filed under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

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