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 - 00840273319825 Catalog Number : 6203-5040S

Device Description : Cervical Reduction Screw Ø5.0x40mm (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 - 00840273319832 Catalog Number : 6203-5045S

Device Description : Cervical Reduction Screw Ø5.0x45mm (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 - 00840273319849 Catalog Number : 6203-5050S

Device Description : Cervical Reduction Screw Ø5.0x50mm (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 - 00840273319856 Catalog Number : 6203-5520S

Device Description : Cervical Reduction Screw Ø5.5x20mm (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 - 00840273319863 Catalog Number : 6203-5525S

Device Description : Cervical Reduction Screw Ø5.5x25mm (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 - 00840273319870 Catalog Number : 6203-5530S

Device Description : Cervical Reduction Screw Ø5.5x30mm (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 - 00840273319887 Catalog Number : 6203-5535S

Device Description : Cervical Reduction Screw Ø5.5x35mm (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 - 00840273319894 Catalog Number : 6203-5540S

Device Description : Cervical Reduction Screw Ø5.5x40mm (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 - 00840273319900 Catalog Number : 6203-5545S

Device Description : Cervical Reduction Screw Ø5.5x45mm (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 - 00840273319917 Catalog Number : 6203-5550S

Device Description : Cervical Reduction Screw Ø5.5x50mm (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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