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Cosmolock 11-RSS-0080

by Kalitec Direct LLC

Cosmolock 11-RSS-0080 is a Class II device made by Kalitec Direct LLC, listed in FDA GUDID since 20 Jun 2023 (UDI-DI B07311RSS00800), 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 NumberB07311RSS00800 UDI-DI Date20 Jun 2023ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Cosmolock
Generic name
Bone-screw internal spinal fixation system rod
Model / Ref / Catalog
11-RSS-0080
Primary DI / UDI-DI
B07311RSS00800
FDA product code
MNH, MNI
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-screw internal spinal fixation system rod

Other devices from Kalitec Direct LLC

See all devices from Kalitec Direct LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)