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Libra Pedicle Screw System LP5535C

by Spinal Balance, Inc.

Libra Pedicle Screw System LP5535C is a Class II device made by Spinal Balance, Inc., cleared under FDA 510(k) K151770 on 20 Nov 2015 and listed in FDA GUDID since 27 May 2016 (UDI-DI 00841327103155), active as of 23 Oct 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 23 Oct 2026

Documents

510(k) K151770

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841327103155 UDI-DI Date27 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151770 Date20 Nov 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151770 decided 20 Nov 2015 Active
  • FDA GUDID UDI-DI 00841327103155 listed 27 May 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151770
  2. Listed FDA GUDID 00841327103155

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Libra Pedicle Screw System
Generic name
Bone-screw internal spinal fixation system, sterile
Model / reference
LP5535C
Primary DI / UDI-DI
00841327103155
510(k) Number
FDA product code
MNH, MNI, NKB
GMDN term
Bone-screw internal spinal fixation system, sterile
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 5.5 Millimeter
Length — 35 Millimeter

Related devices

Category: Bone-screw internal spinal fixation system, sterile

Cleared under the same submission (K151770)

and 8 more cleared under K151770

Similar devices

Other devices filed under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation).

Other devices from Spinal Balance, Inc.

See all devices from Spinal Balance, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)