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Stratis 8000SS

by Covidien LP

Listed FDA GUDID listing, not in commercial distribution

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 Number10884521513778 UDI-DI Date10 Aug 2018ListedStatusListed GUDID: not 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  • Withdrawn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
Stratis
Generic Name
Meniscus screw
Model / Ref / Catalog
8000SS
Primary DI / UDI-DI
10884521513778
510(k) Number
FDA Product Code
KMF
GMDN Term
Meniscus screw
Device Class
Class I
Regulation Number
880.5090
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 8 Millimeter

Related devices

Cleared under the same submission (K041749)

Other devices from Covidien LP

See all devices from Covidien LP →

Properties

  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: 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