K1 MEDICAL TECHNOLOGIES, LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tray, Surgical, Instrument (FSM) (10)

Premarket Exempt

Yes No

Clear

EZ-TRAX™ - 00850006159451 Catalog Number :

Device Description : Bracket Silicone (H) 2.4 Standard Round Dia. .4375

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159475 Catalog Number : BRACKETASSY-S-2.4-STDRD-0.50

Device Description : Bracket Silicone (H) 2.4 Standard Round Dia. .500

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159499 Catalog Number :

Device Description : Bracket Silicone (H) 2.4 Standard Round Dia. .750

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159505 Catalog Number :

Device Description : Bracket Silicone (H) 2.4 Standard Round Dia. .875

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159512 Catalog Number :

Device Description : Bracket Silicone (H) 2.4 Standard Round Dia. 1.00

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159536 Catalog Number :

Device Description : TKA Trial Base

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159543 Catalog Number : 082 MMT.TKA.TIBTRIALINSERTSTD

Device Description : Tibia Trial Insert

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159550 Catalog Number : 083 MMT.TKA.PINDRILLS

Device Description : Pin Drill Base

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159567 Catalog Number : 084 MMT.THA.REAMERS

Device Description : Reamer Base

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159574 Catalog Number : 085 MMT.THA.BROACHBASE

Device Description : Broach Base

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

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