510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN180065Unknown

OGmend Implant System

woven Orthopedic Technologies, Manchester CT / Direct, Unknown
FDA source (opens on fda.gov)

DEN180065 is the FDA 510(k) clearance record for OGmend Implant System, a class II device, cleared for Woven Orthopedic Technologies, LLC on under FDA product code QAC (Screw Sleeve Bone Fixation Device). FDA's definition for product code QAC reads: "A 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 threads...". FDA records list 3 510(k) clearances for Woven Orthopedic Technologies, LLC, from to . As of , FDA records show no recalls naming DEN180065.

Clearance record

Decision date
Received
(505 days to decision)
Product code
QAC Screw Sleeve Bone Fixation Device
Regulation
21 CFR 888.3043
Device class
Class II
Review panel
Orthopedic
Applicant
Woven Orthopedic Technologies, LLC 63 E. Center St., Manchester CT
Third party review
No

Clearances, product code QAC

Trailing 12 months

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

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