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Novel Spinal Spacer System 64118-106

by Alphatec Spine, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00844856064942 UDI-DI Date31 Aug 2015ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Novel Spinal Spacer System
Generic Name
Polymeric spinal interbody fusion cage
Model / Reference
64118-106
Description
Novel LCC, 25 M-5deg, 6mm, PEEK
Primary DI / UDI-DI
00844856064942
510(k) Number
FDA Product Code
MQP
GMDN Term
Polymeric spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 25 Millimeter
Width — 10 Millimeter
Height — 6 Millimeter
Angle — 5 degree

Related devices

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K042201)

Show all (12)

Other devices from Alphatec Spine, Inc.

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No