510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220030Unknown

RemeOs™ Screw LAG Solid

Bioretec Ltd., Tampere, FI / Direct, Unknown
FDA source (opens on fda.gov)

DEN220030 is the FDA 510(k) clearance record for RemeOs™ Screw LAG Solid, a class II device, cleared for Bioretec, Ltd. on under FDA product code QJD (Absorbable Metallic Bone Fixation Fastener). FDA's definition for product code QJD reads: "An absorbable metallic bone fixation fastener is an implant, such as a bone screw, pin, or Kirschner wire, composed of one or more absorbable metal or metal alloys and intended to provide rigid bone fixation suitable for osteosynthesis...". FDA records list 9 510(k) clearances for Bioretec, Ltd., from to . As of , FDA records show no recalls naming DEN220030.

Clearance record

Decision date
Received
(329 days to decision)
Product code
QJD Absorbable Metallic Bone Fixation Fastener
Regulation
21 CFR 888.3041
Device class
Class II
Review panel
Orthopedic
Applicant
Bioretec, Ltd. Yrittäjänkulma 5, Tampere, FI
Third party review
No

Clearances, product code QJD

Trailing 12 months

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

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