510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Augmedics Ltd.

Elgin, IL, US

AUGMEDICS LTD. appears in FDA device records in Elgin, IL. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 7 510(k) clearances for Augmedics Ltd. between 2019 and 2026. The busiest year on record is 2025, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Augmedics Ltd., by decision year
YearClearances
20191
20211
20221
20241
20252
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261854xvision Spine systemSBFSubstantially Equivalent
K251639xvision Spine systemSBFSubstantially Equivalent
K250255xvision Spine systemSBFSubstantially Equivalent
K241481xvision Spine SystemSBFSubstantially Equivalent
K220905xvision Spine SystemSBFSubstantially Equivalent
K211188xvision Spine system (XVS)SBFSubstantially Equivalent
K190929xvision Spine system (XVS)SBFSubstantially Equivalent

Registered establishments

FDA registered establishments for Augmedics Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30165661463016566146AUGMEDICS LTD.2580 Northwest Parkway, Elgin, IL 60124 US2026
30165717113016571711Augmedics Ltd.2 Ha-Otsma St, Yokneam Illit Northern 2069205 IL2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1761-2025Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain