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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Devices

BrandModelCompanyProduct codesPrimary DI
Navigation Software Spine & Trauma 3D2.5Brainlab SEHAW04056481000714
Drill Guide Tube 2.4 150 Mm41839-27Brainlab SEHAW04056481100100
Igs Handle Softgrip 'Universal'55830-15Brainlab SEHAW04056481001285
Spine Reference X-Clamp Size L55752Brainlab SEHAW04056481005221
Spine Probe Tip Set - Thoracic55833Brainlab SEHAW04056481005146
Radiolucent Spine Reference Clamp55756CBrainlab SEHAW04056481001605
Drill Guide Tube 6.0 X 142 Mm Tfs41839-55Brainlab SEHAW04056481003401
Spine Reference X-Clamp Size S55751Brainlab SEHAW04056481005238
Igs Handle Softgrip 'Gearshift'55830-10ABrainlab SEHAW04056481001308
Bone Fixator 1-Pin, X-Press Size-M52422ABrainlab SEHAW04056481002367
Calibration Insert Spinal Probe 3.62Mm53520Brainlab SEHAW04056481005481
Refl. Marker Disks (Single Use, 3 Pcs)55760-03Brainlab SEHAW04056481001582
Scanner Reference Adapter Bodytom19134-10Brainlab SEHAW04056481004668
Calibration Adapter Siemens 3D C-Arm22785Brainlab SEHAW04056481006310
Ziehm Fd 2D Calibration Plate55736Brainlab SEHAW04056481005252
Navigation Software Spine & Trauma 3D2.1Brainlab SEHAW04056481000721
Spine Probe Tip Set - Lumbar55834Brainlab SEHAW04056481005139
Igs Probe 5.5Mm Ulrich Tangors55830-64Brainlab SEHAW04056481001148
Igs Awl Ulrich Tango Rs55830-60ABrainlab SEHAW04056481001155
Igs Probe 7.5Mm Ulrich Tangors55830-66Brainlab SEHAW04056481001124
Fluoro Registration Kit (Rev.1)41705ABrainlab SEHAW04056481003883
Bl Pointer, Sharp-Tip-Extended52780Brainlab SEHAW04056481005795
Igs Probe 6.5Mm Ulrich Tangors55830-65Brainlab SEHAW04056481001131