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Libra 20-8012-010-01

by Synvasive Technology, Inc.

Libra 20-8012-010-01 is a Class I device made by Synvasive Technology, Inc., listed in FDA GUDID since 7 Jul 2016 (UDI-DI 00889024355637), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024355637 UDI-DI Date7 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Libra
Generic name
Knee arthroplasty force sensor balance kit
Model / Ref / Catalog
20-8012-010-01
Primary DI / UDI-DI
00889024355637
FDA product code
LXH
GMDN term
Knee arthroplasty force sensor balance kit
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code LXH (Orthopedic Manual Surgical Instrument).

Other devices from Synvasive Technology, Inc.

See all devices from Synvasive Technology, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)