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RevoMotion 8RG2-40EC-A

by Arthrosurface Incorporated

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM5288RG240ECA0 UDI-DI Date21 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
RevoMotion
Generic Name
Total reverse shoulder prosthesis
Model / Reference
8RG2-40EC-A
Primary DI / UDI-DI
M5288RG240ECA0
510(k) Number
FDA Product Code
PHX
GMDN Term
Total reverse shoulder prosthesis
Device Class
Class II
Regulation Number
888.3660
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Related devices

Cleared under the same submission (K203375)

Show all (12)

Other devices from Arthrosurface Incorporated

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (9)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No