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

Austin, TX, US

Wenzel Spine appears in FDA device records in Austin, TX. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
15
PMA records
0
Recall records
4
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Wenzel Spine carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Ortho Kinematics, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 15 510(k) clearances for Wenzel Spine between 2010 and 2025. The busiest year on record is 2013, with 3. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Wenzel Spine, by decision year
YearClearances
20101
20112
20133
20141
20151
20173
20191
20232
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250247panaSIa SI Fusion SystemOURSubstantially Equivalent
K231076VariLift®-C Interbody Fusion SystemODPSubstantially Equivalent
K231807primaLOK™ SP Interspinous Fusion SystemPEKSubstantially Equivalent
K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemMAXSubstantially Equivalent
K173247Surgical Planning Software version 1.1LLZSubstantially Equivalent
K172327VMA™ System version 3.0LLZSubstantially Equivalent
K171617OKI Surgical Planning SoftwareLLZSubstantially Equivalent
K151900VariLift-L Interbody Fusion DeviceMAXSubstantially Equivalent
K133875THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATALLZSubstantially Equivalent
K131296VARILIFT-L INTERBODY FUSION DEVICEMAXSubstantially Equivalent
K130743THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLLLZSubstantially Equivalent
K120603VARILIFT -CODPSubstantially Equivalent
K112109THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICELLZSubstantially Equivalent
K111123VARILIFT CERVICAL INTERBODY FUSION SYSTEMODPSubstantially Equivalent
K100820WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEMMAXSubstantially Equivalent

Registered establishments

FDA registered establishments for Wenzel Spine, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30061725363006172536Wenzel Spine2535 Brockton Dr Ste 450, Austin, TX 78758 US2026

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-2889-2018Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiologicalThis email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.Class IIOpen, Classified
Z-2891-2018Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed.Class IIOpen, Classified
Z-2882-2018Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred due to a software bug that has been corrected.Class IIOpen, Classified
Z-2890-2018Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.Class IIOpen, Classified

Verification record

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