510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233223Substantially Equivalent

OGmend® Implant Enhancement System

woven Orthopedic Technologies, Manchester CT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233223 is the FDA 510(k) clearance record for OGmend® Implant Enhancement System, a class II device, cleared for Woven Orthopedic Technologies on under FDA product code QVI (Screw Sleeve Bone Fixation Device, Spine). FDA's definition for product code QVI reads: "A spinal screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw...". FDA records list 3 510(k) clearances for Woven Orthopedic Technologies, from to . As of , FDA records show no recalls naming K233223.

Clearance record

Decision date
Received
(28 days to decision)
Product code
QVI Screw Sleeve Bone Fixation Device, Spine
Regulation
21 CFR 888.3043
Device class
Class II
Review panel
Orthopedic
Applicant
Woven Orthopedic Technologies 63 E Center St., #3a, Manchester CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QVI

Trailing 12 months

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

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