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X-Pac SV2452

by Spine View, Inc.

X-Pac SV2452 is a Class II device made by Spine View, Inc., cleared under FDA 510(k) K152539 on 24 Feb 2016 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00853954003234), 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) K152539

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 Number00853954003234 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152539 Date24 Feb 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152539 decided 24 Feb 2016 Active
  • FDA GUDID UDI-DI 00853954003234 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152539
  2. Listed FDA GUDID 00853954003234

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
X-Pac
Generic name
Metallic spinal fusion cage, non-sterile
Model / Ref / Catalog
SV2452
Primary DI / UDI-DI
00853954003234
510(k) Number
FDA product code
MAX
GMDN term
Metallic spinal fusion cage, non-sterile
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Metallic spinal fusion cage, non-sterile

Cleared under the same submission (K152539)

and 8 more cleared under K152539

Similar devices

Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Other devices from Spine View, Inc.

  • X-Pac SV2461

    Class II

  • X-Pac SV2458

    Class II

  • X-Pac SV2456

    Class II

  • X-Pac SV2453

    Class II

See all devices from Spine View, Inc. →

Properties

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