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OptiMesh Multiplanar Expandable Interbody Fusion System 102-79-01

by Spineology Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 NumberM7401001353 UDI-DI Date7 Nov 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
OptiMesh Multiplanar Expandable Interbody Fusion System
Generic Name
Surgical instrument assist arm system, manually-adjusted
Model / Ref / Catalog
102-79-01, 100-1353
Primary DI / UDI-DI
M7401001353
FDA Product Code
LXH
GMDN Term
Surgical instrument assist arm system, manually-adjusted
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Unsafe

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No