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ATEC Lateral Navigation Instruments

by Alphatec Spine, Inc.

510(k) K223765

ATEC Lateral Navigation Instruments is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K223765 on 23 Mar 2023, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK223765 Date23 Mar 2023ClearedStatusActive

Official records

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1343-2026 FDA Class II initiated 2 Jan 2026
    • Ongoing Z-1342-2026 FDA Class II initiated 2 Jan 2026

    Due a design issue where the navigated array connection geometry is incorrect.

Timeline

3 dated events

  1. Cleared FDA 510(k) K223765
  2. Recall initiated FDA recalls Z-1343-2026
  3. Recall initiated FDA recalls Z-1342-2026

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  • Withdrawn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
OLO
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K223765

41 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K223765
UDI-DISize and differences
ATEC Lateral Navigation Disc Prep Instruments 266-00-100-N
ALPHATEC SPINE, INC.
266-00-100-N00190376476131
Single use: yes
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-00-100-N-S
ALPHATEC SPINE, INC.
266-00-100-N-S00190376666334
Single use: yes
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-00-210-N
ALPHATEC SPINE, INC.
266-00-210-N00190376476155
Single use: yes
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-00-300-N
ALPHATEC SPINE, INC.
266-00-300-N00190376494692
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-01-000-08-N
ALPHATEC SPINE, INC.
266-01-000-08-N00190376476162
Width 8 mm
Single use: no
No longer on the market
ATEC Lateral Navigation Disc Prep Instruments 266-01-000-10-N
ALPHATEC SPINE, INC.
266-01-000-10-N00190376476179
Width 10 mm
Single use: no
No longer on the market
ATEC Lateral Navigation Disc Prep Instruments 266-01-000-12-N
ALPHATEC SPINE, INC.
266-01-000-12-N00190376476186
Width 12 mm
Single use: no
No longer on the market
ATEC Lateral Navigation Disc Prep Instruments 266-01-000-14-N
ALPHATEC SPINE, INC.
266-01-000-14-N00190376522906
Width 14 mm
Single use: no
No longer on the market
ATEC Lateral Navigation Disc Prep Instruments 266-10-06186500-N
ALPHATEC SPINE, INC.
266-10-06186500-N00190376476193
Width 18 mm; Length 65 mm; Height 6 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-10-06186510-N
ALPHATEC SPINE, INC.
266-10-06186510-N00190376477107
Angle 10 deg; Length 65 mm; Height 6 mm; Width 18 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-10-08186500-N
ALPHATEC SPINE, INC.
266-10-08186500-N00190376476209
Height 8 mm; Width 18 mm; Length 65 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-10-08186510-N
ALPHATEC SPINE, INC.
266-10-08186510-N00190376476216
Length 65 mm; Height 8 mm; Angle 10 deg; Width 18 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-10-10186500-N
ALPHATEC SPINE, INC.
266-10-10186500-N00190376476223
Height 10 mm; Length 65 mm; Width 18 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-10-10186510-N
ALPHATEC SPINE, INC.
266-10-10186510-N00190376476230
Angle 10 deg; Length 65 mm; Height 10 mm; Width 18 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-10-12186500-N
ALPHATEC SPINE, INC.
266-10-12186500-N00190376476247
Length 65 mm; Height 12 mm; Width 18 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-10-12186510-N
ALPHATEC SPINE, INC.
266-10-12186510-N00190376476254
Length 65 mm; Width 18 mm; Height 12 mm; Angle 10 deg
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-12-000-10-N
ALPHATEC SPINE, INC.
266-12-000-10-N00190376476285
Outer Diameter 10 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-12-000-18-N
ALPHATEC SPINE, INC.
266-12-000-18-N00190376476292
Outer Diameter 18 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-13-010-08-N
ALPHATEC SPINE, INC.
266-13-010-08-N00190376476322
Width 8 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-13-010-10-N
ALPHATEC SPINE, INC.
266-13-010-10-N00190376476339
Width 10 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-13-020-08-N
ALPHATEC SPINE, INC.
266-13-020-08-N00190376476353
Width 8 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-13-020-10-N
ALPHATEC SPINE, INC.
266-13-020-10-N00190376476070
Width 10 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-15-000-06-N
ALPHATEC SPINE, INC.
266-15-000-06-N00190376509754
Width 6 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-15-000-08-N
ALPHATEC SPINE, INC.
266-15-000-08-N00190376509761
Width 8 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-15-000-10-N
ALPHATEC SPINE, INC.
266-15-000-10-N00190376509778
Width 10 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-15-000-12-N
ALPHATEC SPINE, INC.
266-15-000-12-N00190376509785
Width 12 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 266-15-000-14-N
ALPHATEC SPINE, INC.
266-15-000-14-N00190376509792
Width 14 mm
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-01-000-10-N
ALPHATEC SPINE, INC.
267-01-000-10-N00190376541471
Single use: no
No longer on the market
ATEC Lateral Navigation Disc Prep Instruments 267-10-06186500-N
ALPHATEC SPINE, INC.
267-10-06186500-N00190376541501
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-10-06186510-N
ALPHATEC SPINE, INC.
267-10-06186510-N00190376541518
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-10-08186500-N
ALPHATEC SPINE, INC.
267-10-08186500-N00190376541525
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-10-08186510-N
ALPHATEC SPINE, INC.
267-10-08186510-N00190376541532
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-10-10186510-N
ALPHATEC SPINE, INC.
267-10-10186510-N00190376541556
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-10-12186510-N
ALPHATEC SPINE, INC.
267-10-12186510-N00190376541570
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-12-000-10-N
ALPHATEC SPINE, INC.
267-12-000-10-N00190376541587
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-12-000-18-N
ALPHATEC SPINE, INC.
267-12-000-18-N00190376541594
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-13-010-10-N
ALPHATEC SPINE, INC.
267-13-010-10-N00190376541617
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-15-000-08-N
ALPHATEC SPINE, INC.
267-15-000-08-N00190376541655
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-15-000-10-N
ALPHATEC SPINE, INC.
267-15-000-10-N00190376541662
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-15-000-12-N
ALPHATEC SPINE, INC.
267-15-000-12-N00190376541679
Single use: no
On the market
ATEC Lateral Navigation Disc Prep Instruments 267-15-000-14-N
ALPHATEC SPINE, INC.
267-15-000-14-N00190376541686
Single use: no
On the market

Similar devices

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