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SD380.115

by Synthes

SD380.115 (SD380115) is a Class I device made by Synthes, listed in FDA GUDID since 4 Feb 2019 (UDI-DI 10886982280329), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886982280329 UDI-DI Date4 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Orthopaedic bone-fragment manipulator, reusable
Model / Ref / Catalog
SD380.115, SD380115
Primary DI / UDI-DI
10886982280329
FDA product code
HXP
GMDN term
Orthopaedic bone-fragment manipulator, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic bone-fragment manipulator, reusable

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)