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Rampart One Lumbar Interbody Fusion System 102-53-01

by Spineology Inc.

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 NumberM7401021292 UDI-DI Date6 Aug 2024ListedStatusListed 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  • Withdrawn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
Rampart One Lumbar Interbody Fusion System
Generic Name
Surgical implant/trial-implant/sizer holder, reusable
Model / Ref / Catalog
102-53-01, 102-1292
Primary DI / UDI-DI
M7401021292
510(k) Number
FDA Product Code
OVD
GMDN Term
Surgical implant/trial-implant/sizer holder, reusable
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Unsafe
Size
Length — 28 Centimeter

Related devices

Category: Surgical implant/trial-implant/sizer holder, reusable

Cleared under the same submission (K192047)

Show all (12)

Other devices from Spineology Inc.

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • 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