Aegis Spine, Inc.

Address:9781 South Meridian Blvd,Englewood,CO,80112,US

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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

Posterior Cervical Screw System (NKG) (10)

Premarket Exempt

No Yes

Clear

Paeon Posterior Cervical Fixation System - 00840273319726 Catalog Number : 6203-4525S

Device Description : Cervical Reduction Screw Ø4.5x25mm (Ø3.5 Neck)

Device Class : 2

Duns Number: 017993061

Premarket Exempt : No

Product Code : NKG

Prescription Use : No

Device Count : 1

Paeon Posterior Cervical Fixation System - 00840273319733 Catalog Number : 6203-4530S

Device Description : Cervical Reduction Screw Ø4.5x30mm (Ø3.5 Neck)

Device Class : 2

Duns Number: 017993061

Premarket Exempt : No

Product Code : NKG

Prescription Use : No

Device Count : 1

Paeon Posterior Cervical Fixation System - 00840273319740 Catalog Number : 6203-4535S

Device Description : Cervical Reduction Screw Ø4.5x35mm (Ø3.5 Neck)

Device Class : 2

Duns Number: 017993061

Premarket Exempt : No

Product Code : NKG

Prescription Use : No

Device Count : 1

Paeon Posterior Cervical Fixation System - 00840273319757 Catalog Number : 6203-4540S

Device Description : Cervical Reduction Screw Ø4.5x40mm (Ø3.5 Neck)

Device Class : 2

Duns Number: 017993061

Premarket Exempt : No

Product Code : NKG

Prescription Use : No

Device Count : 1

Paeon Posterior Cervical Fixation System - 00840273319764 Catalog Number : 6203-4545S

Device Description : Cervical Reduction Screw Ø4.5x45mm (Ø3.5 Neck)

Device Class : 2

Duns Number: 017993061

Premarket Exempt : No

Product Code : NKG

Prescription Use : No

Device Count : 1

Paeon Posterior Cervical Fixation System - 00840273319771 Catalog Number : 6203-4550S

Device Description : Cervical Reduction Screw Ø4.5x50mm (Ø3.5 Neck)

Device Class : 2

Duns Number: 017993061

Premarket Exempt : No

Product Code : NKG

Prescription Use : No

Device Count : 1

Paeon Posterior Cervical Fixation System - 00840273319788 Catalog Number : 6203-5020S

Device Description : Cervical Reduction Screw Ø5.0x20mm (Ø3.5 Neck)

Device Class : 2

Duns Number: 017993061

Premarket Exempt : No

Product Code : NKG

Prescription Use : No

Device Count : 1

Paeon Posterior Cervical Fixation System - 00840273319795 Catalog Number : 6203-5025S

Device Description : Cervical Reduction Screw Ø5.0x25mm (Ø3.5 Neck)

Device Class : 2

Duns Number: 017993061

Premarket Exempt : No

Product Code : NKG

Prescription Use : No

Device Count : 1

Paeon Posterior Cervical Fixation System - 00840273319801 Catalog Number : 6203-5030S

Device Description : Cervical Reduction Screw Ø5.0x30mm (Ø3.5 Neck)

Device Class : 2

Duns Number: 017993061

Premarket Exempt : No

Product Code : NKG

Prescription Use : No

Device Count : 1

Paeon Posterior Cervical Fixation System - 00840273319818 Catalog Number : 6203-5035S

Device Description : Cervical Reduction Screw Ø5.0x35mm (Ø3.5 Neck)

Device Class : 2

Duns Number: 017993061

Premarket Exempt : No

Product Code : NKG

Prescription Use : No

Device Count : 1

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