510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200301Substantially Equivalent

UNiTi ACDF Implant System

Pressio, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200301 is the FDA 510(k) clearance record for UNiTi ACDF Implant System, a class II device, cleared for Pressio, Inc. on under FDA product code PHQ (Anterior Staple As Supplemental Fixation For Fusion). FDA's definition for product code PHQ reads: "Anterior cervical device for supplemental fixation to support a fusion". FDA records list one 510(k) clearance for Pressio, Inc. As of , FDA records show no recalls naming K200301.

Clearance record

Decision date
Received
(363 days to decision)
Product code
PHQ Anterior Staple As Supplemental Fixation For Fusion
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Pressio, Inc. 14785 Omicron Dr., Suite 100, San Antonio TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHQ

Trailing 12 months

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

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