510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K083458Substantially Equivalent

Intramedullary Fixation Rod (Ifs)

Novalign Orthopaedics, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083458 is the FDA 510(k) clearance record for INTRAMEDULLARY FIXATION ROD (IFS), a class II device, cleared for Novalign Orthopaedics, Inc. on under FDA product code HSB (Rod, Fixation, Intramedullary And Accessories). FDA records list one 510(k) clearance for Novalign Orthopaedics, Inc. As of , FDA records show no recalls naming K083458.

Clearance record

Decision date
Received
(80 days to decision)
Product code
HSB Rod, Fixation, Intramedullary And Accessories
Regulation
21 CFR 888.3020
Device class
Class II
Review panel
Orthopedic
Applicant
Novalign Orthopaedics, Inc. 5885 Rigdeway Center Pkwy., Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSB

Trailing 12 months
19 clearances under product code HSB in the twelve months to October 2026, March 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code HSB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20267
April 20261
May 20262
June 20265
July 20260
August 20260
September 20261
October 20260