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BioBrace®

by Conmed Corporation

510(k) K242187

BioBrace® is a Class II device made by Conmed Corporation, cleared under FDA 510(k) K242187 on 27 Nov 2024, active as of 9 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 9 Oct 2026.

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242187 Date27 Nov 2024ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OWW
Device class
Class II
Regulation
21 CFR Part 878.3300
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon).

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