510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162639Substantially Equivalent

Proficient™ Posterior Cervical Spine System

Spine Wave Inc, Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162639 is the FDA 510(k) clearance record for Proficient™ Posterior Cervical Spine System, a class II device, cleared for Spine Wave, Inc. on under FDA product code NKG (Posterior Cervical Screw System). FDA's definition for product code NKG 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)...". FDA records list 59 510(k) clearances for Spine Wave, Inc., from to . As of , FDA records show no recalls naming K162639.

Clearance record

Decision date
Received
(138 days to decision)
Product code
NKG Posterior Cervical Screw System
Regulation
21 CFR 888.3075
Device class
Class II
Review panel
Orthopedic
Applicant
Spine Wave, Inc. 3 Enterprise Dr., Shelton CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NKG

Trailing 12 months
5 clearances under product code NKG in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NKG, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260