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Zodiac 11-2518

by Alphatec Spine, Inc.

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 23 Oct 2026

Documents

510(k) K100685

FDA submission, from GUDID

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 Number00844856062405 UDI-DI Date23 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK100685 Date18 Jun 2010DecidedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

GUDID

Trade name
Zodiac
Generic name
Bone-screw internal spinal fixation system connector
Model / reference
11-2518
Primary DI / UDI-DI
00844856062405
510(k) Number
FDA product code
KWP, MNH, MNI
GMDN term
Bone-screw internal spinal fixation system connector
Device class
Class II
Regulation number
888.3050, 888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 18 Millimeter

Related devices

Category: Bone-screw internal spinal fixation system connector

Cleared under the same submission (K100685)

Show all (12)

Other devices from Alphatec Spine, Inc.

See all devices from Alphatec Spine, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number

Other properties (10)

  • Supplied 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