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Closed Lateral Connector 803845540

by Shandong Weigao Orthopaedic Device Co., Ltd.

Closed Lateral Connector 803845540 is a Class II device made by Shandong Weigao Orthopaedic Device Co., Ltd., cleared under FDA 510(k) K170861 on 4 Aug 2017 and listed in FDA GUDID since 12 Dec 2017 (UDI-DI 06912547395034), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K170861

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06912547395034 UDI-DI Date12 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170861 Date4 Aug 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170861 decided 4 Aug 2017 Active
  • FDA GUDID UDI-DI 06912547395034 listed 12 Dec 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170861
  2. Listed FDA GUDID 06912547395034

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Closed Lateral Connector
Generic name
Bone-screw internal spinal fixation system connector
Model / reference
803845540
Primary DI / UDI-DI
06912547395034
510(k) Number
FDA product code
KWP, NKB
GMDN term
Bone-screw internal spinal fixation system connector
Device class
Class II
Regulation number
888.3050, 888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Bone-screw internal spinal fixation system connector.

Other devices from Shandong Weigao Orthopaedic Device Co., Ltd.

See all devices from Shandong Weigao Orthopaedic Device Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)