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Parallel Guide 24350-2000

by Captiva Spine

Parallel Guide 24350-2000 is a Class I device made by Captiva Spine, cleared under FDA 510(k) K170475 on 5 May 2017 and listed in FDA GUDID since 23 Oct 2026 (UDI-DI M739243502000), active as of 9 Nov 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 9 Nov 2026

Documents

510(k) K170475

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM739243502000 UDI-DI Date23 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170475 Date5 May 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170475 decided 5 May 2017 Active
  • FDA GUDID UDI-DI M739243502000 listed 23 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170475
  2. Listed FDA GUDID M739243502000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Parallel Guide
Generic name
Surgical drill guide, reusable
Model / reference
24350-2000
Primary DI / UDI-DI
M739243502000
510(k) Number
FDA product code
LXH, HXY
GMDN term
Surgical drill guide, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K170475)

and 8 more cleared under K170475

Other devices from Captiva Spine

See all devices from Captiva Spine →

Properties

  • Sterilise before use
  • Lot / batch number
Other properties (13, all answered No)