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ArcPhix System EXARC903028

by Exsomed Corporation GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB487EXARC9030280 UDI-DIDate6 Apr 2018ListedStatusListed GUDID: not 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  • Withdrawn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
ArcPhix System
Generic Name
Orthopaedic implant driver
Model / Ref / Catalog
EXARC903028
Description
ArcPhix Compression Screw System The system includes the implant, two guide wires, one cannulated drill, and a driver.
Primary DI / UDI-DI
B487EXARC9030280
FDA Product Code
HWC, HXI, LXH, HTW
GMDN Term
Orthopaedic implant driver
Device Class
Class II
Regulation Number
888.3040, 888.4540
GUDID distribution status
Not in Commercial Distribution
Size
Length — 28 Millimeter
Outer Diameter — 3.0 Millimeter

Other devices from Exsomed Corporation

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No