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PER Ring Nut 88497

by Premia Spine Ltd

PER Ring Nut 88497 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 18 Oct 2026 (UDI-DI 07290115932461), active as of 2 Nov 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 2 Nov 2026

Documents

510(k) K232719

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290115932461 UDI-DI Date18 Oct 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 07290115932461 listed 18 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232719
  2. Listed FDA GUDID 07290115932461

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PER Ring Nut
Generic name
Bone-screw internal spinal fixation system rod
Model / reference
88497
Primary DI / UDI-DI
07290115932461
510(k) Number
FDA product code
NKB
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution

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

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)