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OptumSI Implant System 11-11570

by Si Solutions, LLC

Listed FDA GUDID listing, no authorization on record

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 Number00850057247251 UDI-DI Date16 Dec 2025ListedStatusListed GUDID: 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  • Withdrawn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
OptumSI Implant System
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Model / Reference
11-11570
Primary DI / UDI-DI
00850057247251
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
MRI Safety
MR Unsafe
Size
Length — 70 Millimeter
Width — 11.5 Millimeter

Related devices

Cleared under the same submission (K251365)

Show all (12)

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Properties

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

Other properties (8)

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