TRIMED, INCORPORATED

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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

Plate, fixation, bone (HRS) (10)

Premarket Exempt

No Yes

Clear

Foot Plates - 00842188100505 Catalog Number : CSP3508

Device Description : CalcanealOsteotomyPlt, 8Stp, 3.5mm

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Foot Plates - 00842188100512 Catalog Number : CSP3510

Device Description : CalcanealOsteotomyPlt,10Stp 3.5mm

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Foot Plates - 00842188100529 Catalog Number : ECP35

Device Description : Evans Plate, Large

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Foot Plates - 00842188100536 Catalog Number : FMP27L

Device Description : 1st Met Osteotomy Plate, Lt, 2.7mm

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Foot Plates - 00842188100543 Catalog Number : FMP27R

Device Description : 1st Met Osteotomy Plate, Rt, 2.7mm

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Foot Plates - 00842188100550 Catalog Number : HP27-S

Device Description : H-Plate, Short, 2.7mm

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Foot Plates - 00842188100567 Catalog Number : HP27-M

Device Description : H-Plate, Medium, 2.7mm

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Foot Plates - 00842188100574 Catalog Number : HP27-XL

Device Description : H-Plate, Extra Long, 2.7mm

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Foot Plates - 00842188100581 Catalog Number : LP35-0

Device Description : Lapidus Plate, 0mm Step

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Foot Plates - 00842188100598 Catalog Number : LP35-1

Device Description : Lapidus Plate, 1mm Step

Device Class : 2

Duns Number: 138041277

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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