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 - 00840273319429 Catalog Number : 6201-5050S

Device Description : Cervical Polyaxial 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 - 00840273319436 Catalog Number : 6201-5520S

Device Description : Cervical Polyaxial 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 - 00840273319443 Catalog Number : 6201-5525S

Device Description : Cervical Polyaxial 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 - 00840273319450 Catalog Number : 6201-5530S

Device Description : Cervical Polyaxial 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 - 00840273319467 Catalog Number : 6201-5535S

Device Description : Cervical Polyaxial 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 - 00840273319474 Catalog Number : 6201-5540S

Device Description : Cervical Polyaxial 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 - 00840273319481 Catalog Number : 6201-5545S

Device Description : Cervical Polyaxial 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 - 00840273319498 Catalog Number : 6201-5550S

Device Description : Cervical Polyaxial Screw Ø5.5x50mm (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 - 00840273319504 Catalog Number : 6202-4520S

Device Description : Cervical Semi Reduction Screw Ø4.5x20mm (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 - 00840273319511 Catalog Number : 6202-4525S

Device Description : Cervical Semi 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

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