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Falco Fusion System Surgical Instruments Tray (Full) 450-001

by McNicoll Chirurgical 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 Number07540161800451 UDI-DI Date27 Mar 2026ListedStatusListed 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  • Withdrawn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
Falco Fusion System Surgical Instruments Tray (Full)
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Model / Reference
450-001
Primary DI / UDI-DI
07540161800451
510(k) Number
FDA Product Code
OJH
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K253611)

Show all (12)

Other devices from McNicoll Chirurgical Inc.

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • 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
  • Expiration Date: No