510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161332Substantially Equivalent

NILE Proximal Fixation Spinal System

K2M, Inc, Leesburg VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161332 is the FDA 510(k) clearance record for NILE Proximal Fixation Spinal System, a class II device, cleared for K2m, Inc. on under FDA product code OWI (Bone Fixation Cerclage, Sublaminar). FDA's definition for product code OWI reads: "Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion". FDA records list 123 510(k) clearances for K2m, Inc., from to . As of , FDA records show no recalls naming K161332.

Clearance record

Decision date
Received
(328 days to decision)
Product code
OWI Bone Fixation Cerclage, Sublaminar
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
K2m, Inc. 600 Hope Pkwy. SE, Leesburg VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWI

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