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MISHA® Knee System, Large, Right 2-1004

by Moximed, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856047005825 UDI-DI Date5 May 2023ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MISHA® Knee System, Large, Right
Generic Name
Implantable knee unloader
Model / Reference
2-1004
Primary DI / UDI-DI
00856047005825
De Novo Number
FDA Product Code
QVV
GMDN Term
Implantable knee unloader
Device Class
Class II
Regulation Number
888.3610
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (DEN220033)

Show all (9)

Other devices from Moximed, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (7)

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