Skip to content

Midas Rex PM700N

by Medtronic Powered Surgical Solutions

Midas Rex PM700N is a Class II device made by Medtronic Powered Surgical Solutions, cleared under FDA 510(k) K160713 on 26 May 2016 and listed in FDA GUDID since 30 Sep 2018 (UDI-DI 00763000172824), 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) K160713

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 Number00763000172824 UDI-DI Date30 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160713 Date26 May 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160713 decided 26 May 2016 Active
  • FDA GUDID UDI-DI 00763000172824 listed 30 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160713
  2. Listed FDA GUDID 00763000172824

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  • Withdrawn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
Surgical power tool system control unit, pneumatic
Model / reference
PM700N
Primary DI / UDI-DI
00763000172824
510(k) Number
FDA product code
OLO
GMDN term
Surgical power tool system control unit, pneumatic
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical power tool system control unit, pneumatic

Cleared under the same submission (K160713)

and 8 more cleared under K160713

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)