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510(k) DEN220030

RemeOs™ Screw LAG Solid by Bioretec, Ltd. — Product Code QJD

DEN220030 is an FDA 510(k) premarket notification submitted by Bioretec, Ltd. for the device "RemeOs™ Screw LAG Solid". The FDA issued a decision of De Novo Granted on March 29, 2023. The device falls under product code QJD (Absorbable Metallic Bone Fixation Fastener), a Class II device regulated under 21 CFR 888.3041. Bioretec, Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 29, 2023
Date Received
May 4, 2022
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Absorbable Metallic Bone Fixation Fastener
Device Class
Class II
Regulation Number
888.3041
Review Panel
OR
Submission Type

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. The device is designed to fully absorb after steosynthesis is achieved.

Other clearances by Bioretec, Ltd.

  • K133950 — ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) (January 22, 2014)
  • K130716 — BIORETEC ACTIVASCREW INTERFERENCE (August 28, 2013)
  • K080879 — ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVAN (June 24, 2008)
  • K081392 — BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACT (June 18, 2008)
  • K072848 — ACTIVASCREW (November 2, 2007)
  • K071863 — ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) (August 31, 2007)
  • K062980 — ACTIVASCREW (November 22, 2006)
  • K061164 — ACTIVAPIN (July 6, 2006)

FDA data resources