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Midas Rex™ 201R1SS

by Medtronic Powered Surgical Solutions

Midas Rex™ 201R1SS is a Class I device made by Medtronic Powered Surgical Solutions, cleared under FDA 510(k) K870157 on 24 Feb 1987 and listed in FDA GUDID since 31 Jul 2016 (UDI-DI 00643169796911), active as of 22 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 22 Oct 2026

Documents

510(k) K870157

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169796911 UDI-DI Date31 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK870157 Date24 Feb 1987DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K870157 decided 24 Feb 1987 Active
  • FDA GUDID UDI-DI 00643169796911 listed 31 Jul 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K870157
  2. Listed FDA GUDID 00643169796911

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  • Withdrawn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™
Generic name
Orthopaedic bur, single-use
Model / reference
201R1SS
Primary DI / UDI-DI
00643169796911
510(k) Number
FDA product code
KFK
GMDN term
Orthopaedic bur, single-use
Device class
Class I
Regulation number
878.4820
GUDID distribution status
In Commercial Distribution

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Properties

  • Supplied sterile
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)