510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NKGClass II

Posterior Cervical Screw System

21 CFR 888.3075 / Orthopedic
FDA source (opens on fda.gov)

NKG is the FDA product code for Posterior Cervical Screw System, a class II device type, regulated under 21 CFR 888.3075. FDA's definition for this code reads: "Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal...". As of , FDA records hold 118 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
NKG
Device name
Posterior Cervical Screw System
FDA definition
Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Regulation
21 CFR 888.3075
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
119
Ingested recalls
6

Clearances, product code NKG

By decision year
119 clearances under product code NKG with a decision year between 2015 and 2026, 2015 the highest year at 17.
Show the numbers
510(k) clearances under FDA product code NKG by decision year
YearClearances
201517
201616
201715
201812
20198
202014
20217
20227
202310
20243
20256
20264

Applicants with the most clearances

Product code NKG
Applicants holding the most 510(k) clearances under product code NKG
ApplicantClearances
Medtronic Sofamor Danek USA Inc7
Orthofix SRL7
Medacta International SA6
Medos International SARL6
Nu Vasive, Incorporated6
Medicrea International5
Globus Medical, Inc.4
K2M, Inc4
L&K Biomed Co.,Ltd.4
Life Spine4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 157 companies shown, in name order