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Fusion Robotic Navigation System

by Alphatec Spine, Inc.

510(k) K232413

Fusion Robotic Navigation System is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K232413 on 8 Sep 2023, 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 found

in data synced 22 Oct 2026

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 · Special NumberK232413 Date8 Sep 2023ClearedStatusActive

Official records

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  • Withdrawn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

Cited by

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

Devices cleared under K232413

175 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 K232413
UDI-DISize and differences
Valence Robotic Navigation System 126-EN-10VG
ALPHATEC SPINE, INC.
126-EN-10VG00190376635552
Single use: no
On the market
Valence Robotic Navigation System 525-08-01
ALPHATEC SPINE, INC.
525-08-0100190376539904
Single use: no
On the market
Valence Robotic Navigation System 525-100
ALPHATEC SPINE, INC.
525-10000190376539911
Single use: no
On the market
Valence Robotic Navigation System 525-16110-030
ALPHATEC SPINE, INC.
525-16110-03000190376539966
Single use: yes
On the market
Valence Robotic Navigation System 525-16110-045
ALPHATEC SPINE, INC.
525-16110-04500190376539997
Single use: yes
On the market
Valence Robotic Navigation System 525-16420
ALPHATEC SPINE, INC.
525-1642000190376540061
Single use: no
On the market
Valence Robotic Navigation System 525-16420-RJ
ALPHATEC SPINE, INC.
525-16420-RJ00190376540078
Single use: no
On the market
Valence Robotic Navigation System 525-16434-045
ALPHATEC SPINE, INC.
525-16434-04500190376540115
Single use: no
On the market
Valence Robotic Navigation System 525-16434-045-RJ
ALPHATEC SPINE, INC.
525-16434-045-RJ00190376540122
Single use: no
On the market
Valence Robotic Navigation System 525-16434-075
ALPHATEC SPINE, INC.
525-16434-07500190376540238
Single use: no
On the market
Valence Robotic Navigation System 525-16434-075-RJ
ALPHATEC SPINE, INC.
525-16434-075-RJ00190376540245
Single use: no
On the market
Valence Robotic Navigation System 525-16434-080-RJ
ALPHATEC SPINE, INC.
525-16434-080-RJ00190376540269
Single use: no
On the market
Valence Robotic Navigation System 525-165
ALPHATEC SPINE, INC.
525-16500190376585659
Single use: no
On the market
Valence Robotic Navigation System 525-17039-040
ALPHATEC SPINE, INC.
525-17039-04000190376540337
Single use: no
On the market
Valence Robotic Navigation System 525-17039-060
ALPHATEC SPINE, INC.
525-17039-06000190376540412
Single use: no
On the market
Valence Robotic Navigation System 525-17039-060-RJ
ALPHATEC SPINE, INC.
525-17039-060-RJ00190376540429
Single use: no
On the market
Valence Robotic Navigation System 525-17039-080
ALPHATEC SPINE, INC.
525-17039-08000190376540498
Single use: no
On the market
Valence Robotic Navigation System 525-17039-085
ALPHATEC SPINE, INC.
525-17039-08500190376540511
Single use: no
On the market
Valence Robotic Navigation System 525-17040-RJ
ALPHATEC SPINE, INC.
525-17040-RJ00190376540580
Single use: no
On the market
Valence Robotic Navigation System 525-17041-RJ
ALPHATEC SPINE, INC.
525-17041-RJ00190376540603
Single use: no
On the market
Valence Robotic Navigation System 525-17139-060-RJ
ALPHATEC SPINE, INC.
525-17139-060-RJ00190376540689
Single use: no
On the market
Valence Robotic Navigation System 525-17139-065
ALPHATEC SPINE, INC.
525-17139-06500190376540696
Single use: no
On the market
Valence Robotic Navigation System 525-17139-070-RJ
ALPHATEC SPINE, INC.
525-17139-070-RJ00190376540726
Single use: no
On the market
Valence Robotic Navigation System 525-17139-075-RJ
ALPHATEC SPINE, INC.
525-17139-075-RJ00190376540740
Single use: no
On the market
Valence Robotic Navigation System 525-17139-080-RJ
ALPHATEC SPINE, INC.
525-17139-080-RJ00190376540764
Single use: no
On the market
Valence Robotic Navigation System 525-17139-095-RJ
ALPHATEC SPINE, INC.
525-17139-095-RJ00190376540825
Single use: no
On the market
Valence Robotic Navigation System 525-17140
ALPHATEC SPINE, INC.
525-1714000190376540832
Single use: no
On the market
Valence Robotic Navigation System 525-17141
ALPHATEC SPINE, INC.
525-1714100190376540856
Single use: no
On the market
Valence Robotic Navigation System 525-17167-030
ALPHATEC SPINE, INC.
525-17167-03000190376540870
Single use: yes
On the market
Valence Robotic Navigation System 525-17413-31
ALPHATEC SPINE, INC.
525-17413-3100190376540962
Single use: no
On the market
Valence Robotic Navigation System 525-17413-41-RJ
ALPHATEC SPINE, INC.
525-17413-41-RJ00190376541037
Single use: no
On the market
Valence Robotic Navigation System 525-17413-52-RJ
ALPHATEC SPINE, INC.
525-17413-52-RJ00190376541099
Single use: no
On the market
Valence Robotic Navigation System 525-17413-55
ALPHATEC SPINE, INC.
525-17413-5500190376541105
Single use: no
On the market
Valence Robotic Navigation System 525-17413-62
ALPHATEC SPINE, INC.
525-17413-6200190376541143
Single use: no
On the market
Valence Robotic Navigation System 525-17413-69-RJ
ALPHATEC SPINE, INC.
525-17413-69-RJ00190376541198
Single use: no
On the market
Valence Robotic Navigation System 525-17413-72
ALPHATEC SPINE, INC.
525-17413-7200190376541204
Single use: no
On the market
Valence Robotic Navigation System 525-17413-72-RJ
ALPHATEC SPINE, INC.
525-17413-72-RJ00190376541211
Single use: no
On the market
Valence Robotic Navigation System 525-240
ALPHATEC SPINE, INC.
525-24000190376560199
Single use: no
On the market
Valence Robotic Navigation System 525-300
ALPHATEC SPINE, INC.
525-30000190376541242
Single use: no
On the market
Valence Robotic Navigation System 525-412-001
ALPHATEC SPINE, INC.
525-412-00100190376617329
Single use: no
On the market
Valence Robotic Navigation System 525-412-004
ALPHATEC SPINE, INC.
525-412-00400190376635576
Single use: no
On the market
Valence Robotic Navigation System 525-421
ALPHATEC SPINE, INC.
525-42100190376610559
Single use: no
On the market
Valence Robotic Navigation System 525-422
ALPHATEC SPINE, INC.
525-42200190376617350
Single use: no
On the market
Valence Robotic Navigation System 525-750
ALPHATEC SPINE, INC.
525-75000190376541327
Single use: no
On the market
Valence Robotic Navigation System 525-810
ALPHATEC SPINE, INC.
525-81000190376541358
Single use: no
On the market
Valence Robotic Navigation System 525-811
ALPHATEC SPINE, INC.
525-81100190376560236
Single use: no
On the market
Valence Robotic Navigation System 525-850
ALPHATEC SPINE, INC.
525-85000190376560267
Single use: no
On the market
Valence Robotic Navigation System 525-851
ALPHATEC SPINE, INC.
525-85100190376560274
Single use: no
On the market
Valence Robotic Navigation System A-71501
ALPHATEC SPINE, INC.
A-7150100190376661629
Single use: no
On the market
Valence Robotic Navigation System CYBERMEDS24
ALPHATEC SPINE, INC.
CYBERMEDS2400190376635682
Single use: no
On the market

Similar devices

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