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VuePoint 8976031P3

by NuVasive, LLC

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) K180198

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887517830364 UDI-DI Date8 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180198 Date15 Mar 2018DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VuePoint
Generic name
Bone-screw internal spinal fixation system connector
Model / reference
8976031P3
Primary DI / UDI-DI
00887517830364
510(k) Number
FDA product code
NKG, KWP
GMDN term
Bone-screw internal spinal fixation system connector
Device class
Class II
Regulation number
888.3075, 888.3050
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

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  • ReLine 3813510

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See all devices from NuVasive, LLC →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (7)

  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No