510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K980788Substantially Equivalent

Alphatec Wire External Fixation System

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

K980788 is the FDA 510(k) clearance record for ALPHATEC WIRE EXTERNAL FIXATION SYSTEM, a class II device, cleared for Alphatec Mfg., Inc. on under FDA product code JDW (Pin, Fixation, Threaded). FDA records list 121 510(k) clearances for ALPHATEC SPINE, INC., from to . As of , FDA records show no recalls naming K980788.

Clearance record

Decision date
Received
(81 days to decision)
Product code
JDW Pin, Fixation, Threaded
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Alphatec Mfg., Inc. 42-160 State St., Palm Desert CA
510(k) summary
Statement
Third party review
No

Clearances, product code JDW

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