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PER Trial 50 89097

by Premia Spine Ltd

PER Trial 50 89097 is a Class II device made by Premia Spine Ltd, cleared under FDA 510(k) K232719 on 21 Nov 2023 and listed in FDA GUDID since 22 Jul 2026 (UDI-DI 07290115935691), active as of 22 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 22 Oct 2026

Documents

510(k) K232719

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290115935691 UDI-DI Date22 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232719 Date21 Nov 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232719 decided 21 Nov 2023 Active
  • FDA GUDID UDI-DI 07290115935691 listed 22 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232719
  2. Listed FDA GUDID 07290115935691

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PER Trial 50
Generic name
Medical ruler, reusable
Model / reference
89097
Primary DI / UDI-DI
07290115935691
510(k) Number
FDA product code
NKB
GMDN term
Medical ruler, reusable
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K232719)

and 8 more cleared under K232719

Other devices from Premia Spine Ltd

See all devices from Premia Spine Ltd →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)