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Mesh 1007694

by NuVasive, LLC

Mesh 1007694 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K023319 on 4 Mar 2003 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00887517055880), 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) K023319

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 Number00887517055880 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK023319 Date4 Mar 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K023319 decided 4 Mar 2003 Active
  • FDA GUDID UDI-DI 00887517055880 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K023319
  2. Listed FDA GUDID 00887517055880

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mesh
Generic name
Vertebral body prosthesis
Model / reference
1007694
Primary DI / UDI-DI
00887517055880
510(k) Number
FDA product code
MQP
GMDN term
Vertebral body prosthesis
Device class
Class II
Regulation number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code MQP (SPINAL VERTEBRAL BODY REPLACEMENT DEVICE).

Other devices from NuVasive, LLC

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  • ReLine 3800240

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See all devices from NuVasive, LLC →

Properties

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