510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K002260Substantially Equivalent

Spina System

North American Medical Corporation (Nam), Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002260 is the FDA 510(k) clearance record for SPINA SYSTEM, a class II device, cleared for North American Medical Corporation (Nam) on under FDA product code ITH (Equipment, Traction, Powered). FDA records list one 510(k) clearance for North American Medical Corporation (Nam). As of , FDA records show no recalls naming K002260.

Clearance record

Decision date
Received
(31 days to decision)
Product code
ITH Equipment, Traction, Powered
Regulation
21 CFR 890.5900
Device class
Class II
Review panel
Physical Medicine
Applicant
North American Medical Corporation (Nam) 6595 Roswell Rd. Suite 811, Atlanta GA
510(k) summary
Summary
Third party review
No

Clearances, product code ITH

Trailing 12 months

FDA records hold no clearances under product code ITH in the trailing twelve months.

FDA records show no clearances under product code ITH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ITH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260