510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K083178Substantially Equivalent

Solas Anatomix Spinal System

Biotechni America Spine Group, Inc., Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083178 is the FDA 510(k) clearance record for SOLAS ANATOMIX SPINAL SYSTEM, a class II device, cleared for Biotechni America Spine Group, Inc. on under FDA product code MNI (Orthosis, Spinal Pedicle Fixation). FDA records list one 510(k) clearance for Biotechni America Spine Group, Inc. As of , FDA records show no recalls naming K083178.

Clearance record

Decision date
Received
(118 days to decision)
Product code
MNI Orthosis, Spinal Pedicle Fixation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Biotechni America Spine Group, Inc. 13203 39th Ave. NE, Seattle WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNI

Trailing 12 months

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

FDA records show no clearances under product code MNI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MNI, 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