510(K) CLEARANCES 63 ▲12RECALLS POSTED 17 ▼8CLASS I 1PMA DECISIONS 48 ▼2WEEK ENDING / FDA DATA AS OF
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K992350Substantially Equivalent

Pylon Intramedullaary Nail System

Alphatec Spine, Inc., Palm Desert CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992350 is the FDA 510(k) clearance record for PYLON INTRAMEDULLAARY NAIL SYSTEM, a class II device, cleared for Alphatec Mfg., Inc. on under FDA product code HSB (Rod, Fixation, Intramedullary And Accessories). FDA records list 121 510(k) clearances for ALPHATEC SPINE, INC., from to . As of , FDA records show no recalls naming K992350.

Clearance record

Decision date
Received
(70 days to decision)
Product code
HSB Rod, Fixation, Intramedullary And Accessories
Regulation
21 CFR 888.3020
Device class
Class II
Review panel
Orthopedic
Applicant
Alphatec Mfg., Inc. 42-160 State St., Palm Desert CA
510(k) summary
Summary
Third party review
No

Clearances, product code HSB

Trailing 12 months
20 clearances under product code HSB in the twelve months to November 2026, March 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code HSB, trailing twelve months
MonthClearances
December 20252
January 20260
February 20261
March 20267
April 20261
May 20262
June 20265
July 20260
August 20260
September 20261
October 20261
November 20260