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Curved Rod, 5.5 x 50 2455-2050

by Captiva Spine 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM73924552050 UDI-DI Date30 Oct 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0413-2013 FDA Class II initiated 20 Sep 2012

    Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Curved Rod, 5.5 x 50
Generic Name
Bone-screw internal spinal fixation system, non-sterile
Model / Reference
2455-2050
Primary DI / UDI-DI
M73924552050
510(k) Number
FDA Product Code
MNH, MNI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K120292)

Show all (12)

Other devices from Captiva Spine

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: 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