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xvision Spine system (XVS)

by Augmedics Ltd 2 variants

510(k) K190929

xvision Spine system (XVS) is a medical device (FDA Class II; FDA product code SBF, Orthopedic Augmented Reality) made by Augmedics Ltd, cleared under FDA 510(k) K190929 on 20 Dec 2019, 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 · Traditional NumberK190929 Date20 Dec 2019ClearedStatusActive

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  • Withdrawn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
SBF
FDA applicant
Augmedics, Ltd.
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 K190929

46 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 K190929
UDI-DISize and differences
All-in-one computer + Pre-installed Software ACC00008
AUGMEDICS LTD.
ACC0000807290113780231
Prescription: yes; Single use: no
On the market
Clamp Removal Tool AMCH02001
AUGMEDICS LTD.
AMCH0200107290113780613
Prescription: yes; Single use: no
On the market
Ergonomic Navigated Tool Adaptor AMC04280
AUGMEDICS LTD.
AMC0428007290113780637
Prescription: yes; Single use: no
On the market
Fixed 3-4mm Universal tool Adapter Leg Down AMCFSD03
AUGMEDICS LTD.
AMCFSD0307290113780408
Prescription: no; Single use: no
On the market
Fixed 3-4mm Universal tool Adapter Leg Up AMCFSU03
AUGMEDICS LTD.
AMCFSU0307290113780071
Prescription: no; Single use: no
On the market
Navigated Tool Adaptor AMC04180
AUGMEDICS LTD.
AMC0418007290113780521
Prescription: no; Single use: no
On the market
Roll stand ACC00045
AUGMEDICS LTD.
ACC0004507290113780248
Prescription: no; Single use: no
On the market
Screwdriver 4MM SCDH00004
AUGMEDICS LTD.
SCDH0000407290113780118
Prescription: yes; Single use: no
On the market
Swivel 4-5 mm universal tool adapter Leg down AMCRMD04
AUGMEDICS LTD.
AMCRMD0407290113780699
Prescription: yes; Single use: no
On the market
Swivel 4-5 mm universal tool adapter Leg up AMCRMU04
AUGMEDICS LTD.
AMCRMU0407290113780682
Prescription: yes; Single use: no
On the market
Swivel 5-6 mm universal tool adapter leg up AMCRMD05
AUGMEDICS LTD.
AMCRMD0507290113780675
Prescription: yes; Single use: no
On the market
Swivel 5-6 mm universal tool adapter leg up AMCRMU05
AUGMEDICS LTD.
AMCRMU0507290113780705
Prescription: yes; Single use: no
On the market
Swivel 6-7.5mm universal tool adapter Leg Down AMCRMD06
AUGMEDICS LTD.
AMCRMD0607290113780668
Prescription: yes; Single use: no
On the market
Swivel 6-7.5mm universal tool adapter Leg up AMCRMU06
AUGMEDICS LTD.
AMCRMU0607290113780651
Prescription: yes; Single use: no
On the market
Swivel 7.5-9.0 mm universal tool adapter Leg up AMCRMU75
AUGMEDICS LTD.
AMCRMU7507290113780644
Prescription: yes; Single use: no
On the market
Swivel 7.5-9mm Universal tool Adapter Leg Down AMCRMD75
AUGMEDICS LTD.
AMCRMD7507290113780064
Prescription: no; Single use: no
On the market
Tablet computer + Pre-installed Software ACC00001
AUGMEDICS LTD.
ACC0000107290113780262
Prescription: yes; Single use: no
On the market
Wireless Router ACOM00001
AUGMEDICS LTD.
ACOM0000107290113780255
Prescription: no; Single use: no
On the market
XVS Arc Clamp AMCH00006
AUGMEDICS LTD.
AMCH0000607290113780019
Prescription: yes; Single use: no
On the market
XVS Foot Switch AFOT0001
AUGMEDICS LTD.
AFOT000107290113780279
Prescription: no; Single use: no
On the market
XVS Headset Battery Case LARGE ACC00112
AUGMEDICS LTD.
ACC0011207290113780415
Prescription: no; Single use: no
On the market
XVS Headset Battery Case SMALL ACC00111
AUGMEDICS LTD.
ACC0011107290113780422
Prescription: no; Single use: no
On the market
XVS Headset Battery Charger APWR0004
AUGMEDICS LTD.
APWR000407290113780309
Prescription: no; Single use: no
On the market
XVS Headset Battery LARGE ABAT00001
AUGMEDICS LTD.
ABAT0000107290113780316
Prescription: no; Single use: no
On the market
XVS Headset Battery SMALL ABAT00002
AUGMEDICS LTD.
ABAT0000207290113780323
Prescription: no; Single use: no
On the market
XVS Headset IPD-60 Clear Display AHMD601WLT
AUGMEDICS LTD.
AHMD601WLT07290113780132
Prescription: yes; Single use: no
On the market
XVS Headset IPD-60 LCD Display AHMD601WLD
AUGMEDICS LTD.
AHMD601WLD07290113780163
Prescription: yes; Single use: no
On the market
XVS Headset IPD-64 Clear Display AHMD641WLT
AUGMEDICS LTD.
AHMD641WLT07290113780149
Prescription: yes; Single use: no
On the market
XVS Headset IPD-64 LCD Display AHMD641WLD
AUGMEDICS LTD.
AHMD641WLD07290113780095
Prescription: yes; Single use: no
On the market
XVS Headset IPD-68 Clear Display AHMD681WLT
AUGMEDICS LTD.
AHMD681WLT07290113780606
Prescription: yes; Single use: no
On the market
XVS Headset IPD-68 LCD Display AHMD681WLD
AUGMEDICS LTD.
AHMD681WLD07290113780583
Prescription: yes; Single use: no
On the market
XVS Instrument Tray for Navigated Tools ASP00011
AUGMEDICS LTD.
ASP0001107290113780286
Prescription: no; Single use: no
On the market
XVS Instrument Tray for Universal Tools ASP00027
AUGMEDICS LTD.
ASP0002707290113780293
Prescription: no; Single use: no
On the market
XVS L-Headset IPD-60 Clear Display AHMD602WLT
AUGMEDICS LTD.
AHMD602WLT07290113780804
Prescription: yes; Single use: no
On the market
XVS L-Headset IPD-60 LCD Display AHMD602WLD
AUGMEDICS LTD.
AHMD602WLD07290113780798
Prescription: yes; Single use: no
On the market
XVS L-Headset IPD-64 Clear Display AHMD642WLT
AUGMEDICS LTD.
AHMD642WLT07290113780828
Prescription: yes; Single use: no
On the market
XVS L-Headset IPD-64 LCD Display AHMD642WLD
AUGMEDICS LTD.
AHMD642WLD07290113780811
Prescription: yes; Single use: no
On the market
XVS L-Headset IPD-68 Clear Display AHMD682WLT
AUGMEDICS LTD.
AHMD682WLT07290113780842
Prescription: yes; Single use: no
On the market
XVS L-Headset IPD-68 LCD Display AHMD682WLD
AUGMEDICS LTD.
AHMD682WLD07290113780835
Prescription: yes; Single use: no
On the market
XVS STERILE COMPONENTS KIT ASP00014
AUGMEDICS LTD.
ASP0001407290113780101
Prescription: yes; Single use: yes
On the market
XVS Straight Clamp AMCH00005
AUGMEDICS LTD.
AMCH0000507290113780002
Prescription: yes; Single use: no
On the market
XVS Tall Straight Clamp 82mm AMCH00007
AUGMEDICS LTD.
AMCH0000707290113780620
Prescription: yes; Single use: no
On the market
XVS VP Adaptor AMC00001
AUGMEDICS LTD.
AMC0000107290113780507
Prescription: no; Single use: no
On the market
XVS Wrench AMCH00030
AUGMEDICS LTD.
AMCH0003007290113780514
Prescription: no; Single use: no
On the market
Z-marker-40 AMCH01040
AUGMEDICS LTD.
AMCH0104007290113780033
Prescription: yes; Single use: no
On the market
Z-marker-60 AMCH01060
AUGMEDICS LTD.
AMCH0106007290113780026
Prescription: yes; Single use: no
On the market

Similar devices

Other devices filed under FDA product code SBF (Orthopedic Augmented Reality).

Other devices from Augmedics Ltd.

See all devices from Augmedics Ltd. →