Biopoly, LLC

Address:7136 Gettysburg Pike,Fort Wayne,IN,46804,US

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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

Prosthesis, Toe, Hemi-, Phalangeal (KWD) (5)

Premarket Exempt

Clear

BioPoly® Great Toe Hemiarthroplasty Implant - 00850005618195 Catalog Number : 135-5122

Device Description : BioPoly® Great Toe Hemiarthroplasty Implant - 22mm Porous

Device Class : 2

Duns Number: 023778928

Premarket Exempt : No

Product Code : KWD

Prescription Use : Yes

Device Count : 1

BioPoly® Great Toe Hemiarthroplasty Implant - 00850012119388 Catalog Number : 135-5114

Device Description : BioPoly® Great Toe Hemiarthroplasty Implant - 14mm Porous

Device Class : 2

Duns Number: 023778928

Premarket Exempt : No

Product Code : KWD

Prescription Use : Yes

Device Count : 1

BioPoly® Great Toe Hemiarthroplasty Implant - 00850012119395 Catalog Number : 135-5116

Device Description : BioPoly® Great Toe Hemiarthroplasty Implant - 16mm Porous

Device Class : 2

Duns Number: 023778928

Premarket Exempt : No

Product Code : KWD

Prescription Use : Yes

Device Count : 1

BioPoly® Great Toe Hemiarthroplasty Implant - 00850012119401 Catalog Number : 135-5118

Device Description : BioPoly® Great Toe Hemiarthroplasty Implant - 18mm Porous

Device Class : 2

Duns Number: 023778928

Premarket Exempt : No

Product Code : KWD

Prescription Use : Yes

Device Count : 1

BioPoly® Great Toe Hemiarthroplasty Implant - 00850012119418 Catalog Number : 135-5120

Device Description : BioPoly® Great Toe Hemiarthroplasty Implant - 20mm Porous

Device Class : 2

Duns Number: 023778928

Premarket Exempt : No

Product Code : KWD

Prescription Use : Yes

Device Count : 1

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