Osteosymbionics, 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

Plate, Cranioplasty, Preformed, Non-Alterable (GXN) (3) Implant, Temporal (MNF) (2)

Premarket Exempt

Clear

ClearShield (Non-Sterile) - 00866453000109 Catalog Number :

Device Description : PMMA Patient Specific Cranial Implant (Non-Sterile)

Device Class : 2

Duns Number: 858769651

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

ClearShield (Sterile) - 00866453000116 Catalog Number :

Device Description : PMMA Patient Specific Cranial Implant (Sterile)

Device Class : 2

Duns Number: 858769651

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

PK Shield - 00866453000123 Catalog Number :

Device Description : PEEK Patient Specific Cranial Implant

Device Class : 2

Duns Number: 858769651

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

ST Temporalis - 00866453000130 Catalog Number :

Device Description : Silicone Temporal Implant - Small

Device Class : 2

Duns Number: 858769651

Premarket Exempt : No

Product Code : MNF

Prescription Use : Yes

Device Count : 1

ST Temporalis - 00866453000147 Catalog Number :

Device Description : Silicone Temporal Implant - Large

Device Class : 2

Duns Number: 858769651

Premarket Exempt : No

Product Code : MNF

Prescription Use : Yes

Device Count : 1

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