Skip to content

Lancer Open Pedicle Screw System M070-0133

by Choicespine, LP 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00840996177399 UDI-DI Date20 Jun 2019ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Lancer Open Pedicle Screw System
Generic Name
External spinal fixation system
Model / Reference
M070-0133
Primary DI / UDI-DI
00840996177399
510(k) Number
FDA Product Code
LHX
GMDN Term
External spinal fixation system
Device Class
Class II
Regulation Number
870.5800
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Metallic spinal fusion cage, non-sterile

Cleared under the same submission (K160775)

Show all (12)

Cleared under the same submission (K180519)

Show all (12)

Other devices from Choicespine, LP

See all devices from Choicespine, LP →

Properties

  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: 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