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Zavation Rod 380-MS200

by Zavation GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00197157079833 UDI-DIDate12 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Zavation Rod
Generic Name
Orthopaedic bone pin, non-bioabsorbable
Model / Reference
380-MS200
Primary DI / UDI-DI
00197157079833
510(k) Number
FDA Product Code
NKB, KWP, KWQ
GMDN Term
Orthopaedic bone pin, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3070, 888.3050, 888.3060
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K243908)

Show all (12)

Other devices from Zavation

See all devices from Zavation →

Properties

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

Other properties (10)

  • Sterile: 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