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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Theken Spine, LLC — Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time
126 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K121482INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERYTheken Spine, LLC2012-08-281020
K121211VU APOD INTERVERTEBRAL BODY FUSION DEVICETheken Spine, LLC2012-06-27680
K120829STAINLESS STEEL SPINAL SYSTEMTheken Spine, LLC2012-05-30720
K120047CORAL SPINAL SYSTEMTheken Spine, LLC2012-02-03280
K111675VU C*POD INTERVERTEBRAL BODY FUSION DEVICETheken Spine, LLC2011-08-02480
K103228PARAMOUNT R IBF DEVICETheken Spine, LLC2011-01-05640
K102323CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICETheken Spine, LLC2010-12-161210
K101310VU APOD INTERVERTEBRAL BODY FUSION DEVICETheken Spine, LLC2010-09-021140
K100970STAINLESS STEEL SPINAL SYSTEMTheken Spine, LLC2010-08-121260
K091266THEKEN CORAL SPINAL SYSTEMTheken Spine, LLC2009-06-10410
K083863THEKEN ATOLL OCT SPINAL SYSTEMTheken Spine, LLC2009-03-27880
K083073THEKEN ATOLL CERVICO-THORACIC SYSTEMTheken Spine, LLC2009-03-131490
K082712THEKEN SPINE VU EPOD AND VU LPOD SYSTEMTheken Spine, LLC2009-01-021080
K080822VU APOD INTERVERTABRAL BODY FUSION DEVICETheken Spine, LLC2008-07-021001
K081414MODIFICATION TO CORAL SPINAL SYSTEMTheken Spine, LLC2008-06-17280
K080790MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEMTheken Spine, LLC2008-04-29400
K080690MANTA RAY ANTERIOR CERVICAL PLATE SYSTEMTheken Spine, LLC2008-04-25452
K072407BODYFORM THORACIC FIXATION SYSTEMTheken Spine, LLC2007-12-211160
K070962CORAL PEDICLE SCREW SYSTEMTheken Spine, LLC2007-08-221390
K071031VU E*POD VERTEBRAL BODY REPLACEMENTTheken Spine, LLC2007-07-301100
K070786X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENTTheken Spine, LLC2007-06-28980
K070638THEKEN ATOLL CERVICO-THORACIC SYSTEMTheken Spine, LLC2007-05-30840
K070381THEKEN VU MESH VBR SYSTEMTheken Spine, LLC2007-04-25760

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda