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Novel Spinal Spacer System

by Alphatec Spine, Inc.

510(k) K080699

Novel Spinal Spacer System is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K080699 on 21 May 2008, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080699 Date21 May 2008ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-0190-2010 FDA Unclassified (pre-2012) initiated 13 May 2009 on shared 510(k) K080699

    Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

2 dated events

  1. Cleared FDA 510(k) K080699
  2. Recall initiated FDA recalls Z-0190-2010

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MQP
Device class
Class II
Regulation
21 CFR Part 888.3060
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

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