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ZERO Profile Interlocking Cortex Screw, 3.5mm x 80mm, T15, Flex-Thread™ 8525-80-S

by Flower Orthopedics Corporation

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 Number00840118117098 UDI-DI Date19 Mar 2021ListedStatusListed 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  • Withdrawn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
ZERO Profile Interlocking Cortex Screw, 3.5mm x 80mm, T15, Flex-Thread™
Generic Name
Orthopaedic bone screw (non-sliding)
Model / Reference
8525-80-S
Primary DI / UDI-DI
00840118117098
FDA Product Code
HSB
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 3.5 Millimeter
Length — 80 Millimeter

Related devices

Category: General internal orthopaedic fixation system implantation kit

Other devices from Flower Orthopedics Corporation

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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