Skip to content

Midas Rex Legend 10BA10DL-Mn

by Medtronic Powered Surgical Solutions

Midas Rex Legend 10BA10DL-Mn is a Class II device made by Medtronic Powered Surgical Solutions, cleared under FDA 510(k) K170312 on 15 May 2017 and listed in FDA GUDID since 22 Jan 2022 (UDI-DI 00763000444235), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K170312

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000444235 UDI-DI Date22 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170312 Date15 May 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170312 decided 15 May 2017 Active
  • FDA GUDID UDI-DI 00763000444235 listed 22 Jan 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170312
  2. Listed FDA GUDID 00763000444235

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Midas Rex Legend
Generic name
Orthopaedic bur, single-use
Model / reference
10BA10DL-MN
Primary DI / UDI-DI
00763000444235
510(k) Number
FDA product code
HBB
GMDN term
Orthopaedic bur, single-use
Device class
Class II
Regulation number
882.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic bur, single-use

Cleared under the same submission (K170312)

and 8 more cleared under K170312

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)