Ascension Orthopedics, Inc.

Address:11101 Metric Blvd,Austin,TX,78758,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

High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis (OMX) (8) Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis (NEG) (2)

Premarket Exempt

No Yes

Clear

Ascension® MCP - 10381780000440 Catalog Number : MCP-100-50D-WW

Device Description : Metacarpal-Phalangeal Joint Replacement Device

Device Class : 3

Duns Number: 942377524

Premarket Exempt : No

Product Code : NEG

Prescription Use : Yes

Device Count : 1

Ascension® MCP - 10381780000457 Catalog Number : MCP-100-50P-WW

Device Description : Metacarpal-Phalangeal Joint Replacement Device

Device Class : 3

Duns Number: 942377524

Premarket Exempt : No

Product Code : NEG

Prescription Use : Yes

Device Count : 1

Ascension PIP - 10381780000464 Catalog Number : PIP-200-10P-WW

Device Description : Proximal Inter-Phalangeal Joint Replacement Device

Device Class :

Duns Number: 942377524

Premarket Exempt : No

Product Code : OMX

Prescription Use : Yes

Device Count : 1

Ascension PIP - 10381780000471 Catalog Number : PIP-200-20P-WW

Device Description : Proximal Inter-Phalangeal Joint Replacement Device

Device Class :

Duns Number: 942377524

Premarket Exempt : No

Product Code : OMX

Prescription Use : Yes

Device Count : 1

Ascension PIP - 10381780000488 Catalog Number : PIP-200-30P-WW

Device Description : Proximal Inter-Phalangeal Joint Replacement Device

Device Class :

Duns Number: 942377524

Premarket Exempt : No

Product Code : OMX

Prescription Use : Yes

Device Count : 1

Ascension PIP - 10381780000495 Catalog Number : PIP-200-40P-WW

Device Description : Proximal Inter-Phalangeal Joint Replacement Device

Device Class :

Duns Number: 942377524

Premarket Exempt : No

Product Code : OMX

Prescription Use : Yes

Device Count : 1

Ascension PIP - 10381780000501 Catalog Number : PIP-200-10D-WW

Device Description : Proximal Inter-Phalangeal Joint Replacement Device

Device Class :

Duns Number: 942377524

Premarket Exempt : No

Product Code : OMX

Prescription Use : Yes

Device Count : 1

Ascension PIP - 10381780000518 Catalog Number : PIP-200-20D-WW

Device Description : Proximal Inter-Phalangeal Joint Replacement Device

Device Class :

Duns Number: 942377524

Premarket Exempt : No

Product Code : OMX

Prescription Use : Yes

Device Count : 1

Ascension PIP - 10381780000525 Catalog Number : PIP-200-30D-WW

Device Description : Proximal Inter-Phalangeal Joint Replacement Device

Device Class :

Duns Number: 942377524

Premarket Exempt : No

Product Code : OMX

Prescription Use : Yes

Device Count : 1

Ascension PIP - 10381780000532 Catalog Number : PIP-200-40D-WW

Device Description : Proximal Inter-Phalangeal Joint Replacement Device

Device Class :

Duns Number: 942377524

Premarket Exempt : No

Product Code : OMX

Prescription Use : Yes

Device Count : 1

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