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NEXXT MATRIXX® Stand Alone Cervical System 52-1618-10-ASM

by Nexxt Spine LLC

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

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 Number00889929033586 UDI-DI Date2 Jul 2019ListedStatusListed GUDID: not in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
NEXXT MATRIXX® Stand Alone Cervical System
Generic Name
Metallic spinal interbody fusion cage
Model / Reference
52-1618-10-ASM
Primary DI / UDI-DI
00889929033586
510(k) Number
FDA Product Code
OVE
GMDN Term
Metallic spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
Not in Commercial Distribution
Size
Height — 10 Millimeter
Angle — 6 degree
Depth — 16 Millimeter
Width — 18 Millimeter

Related devices

Cleared under the same submission (K190546)

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Other devices from Nexxt Spine LLC

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No