Skip to content

ZESPIN SI Joint Fusion System 1023-7050S

by Aegis Spine, 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 Number00840273311898 UDI-DI Date6 May 2022ListedStatusListed 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  • Withdrawn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
ZESPIN SI Joint Fusion System
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Model / Ref / Catalog
1023-7050S
Primary DI / UDI-DI
00840273311898
510(k) Number
FDA Product Code
OUR
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

Cleared under the same submission (K210035)

Show all (12)

Other devices from Aegis Spine, Inc.

See all devices from Aegis Spine, Inc. →

Properties

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

Other properties (10)

  • Contains Latex: No
  • Prescription Use: 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