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

Clearance record K212381

VersaTap, VersaLat, DueLock, VersaTi, MiniTi · Ortho-Design (Pty), Ltd. · decided 2021-12-06 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Anchor Threaded Titanium-PEEKATX-6.5x17 STORTHO-DESIGN (PTY) LTDMBI06009712642809
Anchor Threaded TitaniumATT-3x11 2S NORTHO-DESIGN (PTY) LTDMBI06009712642748
MiniTiATP003ORTHO-DESIGN (PTY) LTDMBI06009712641666
Anchor Threaded TitaniumATT-2x6 2S NDORTHO-DESIGN (PTY) LTDMBI06009712642731
VersaTiATP002ORTHO-DESIGN (PTY) LTDMBI06009712641628
VersaTapADP005ORTHO-DESIGN (PTY) LTDMBI06009712641642
VersaTapADP001ORTHO-DESIGN (PTY) LTDMBI06009712641581
Anchor Threaded Titanium-PEEKATX-6.5x17 2SORTHO-DESIGN (PTY) LTDMBI06009712642793
DueLockADP011ORTHO-DESIGN (PTY) LTDMBI06009712641635
VersaTiATP001ORTHO-DESIGN (PTY) LTDMBI06009712641611
VersaPEEKAPP001ORTHO-DESIGN (PTY) LTDMBI06009712642236
Anchor Threaded Titanium-PEEKATX-6.5x17 2TORTHO-DESIGN (PTY) LTDMBI06009712642816
VersaTapADP001-T2ORTHO-DESIGN (PTY) LTDMBI06009712640591
VersaTapADP001-T1ORTHO-DESIGN (PTY) LTDMBI06009712640584
VersaTiATP004ORTHO-DESIGN (PTY) LTDMBI06009708899484
Anchor Threaded PEEKATP-5.5x15 2S NORTHO-DESIGN (PTY) LTDMBI06009712642786
Anchor Threaded TitaniumATT-4x13 2S NORTHO-DESIGN (PTY) LTDMBI06009712642755
VersaPEEKAPP001-NORTHO-DESIGN (PTY) LTDMBI06009712642250
Anchor Impact PEEKABP-2.9x10 S NORTHO-DESIGN (PTY) LTDMBI06009712642779
Anchor Threaded TitaniumATT-6x17 2S NORTHO-DESIGN (PTY) LTDMBI06009712642762
Anchor Threaded Titanium-PEEKATX-6.5x17 2S NORTHO-DESIGN (PTY) LTDMBI06009712642823