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

Round Rock, TX, US

Corelink, LLC appears in FDA device records in Round Rock, TX. FDA records list 35 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
35
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 35 510(k) clearances for Corelink, LLC between 2008 and 2023. The busiest year on record is 2023, with 6. The most recent is 2023, with 6.

Clearances by year, as a table
510(k) clearance decisions for Corelink, LLC, by decision year
YearClearances
20081
20111
20125
20133
20141
20151
20161
20172
20183
20192
20203
20212
20224
20236
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystemMAXSubstantially Equivalent
K231494CoreLink Robotic Navigation InstrumentsOLOSubstantially Equivalent
K232116CoreLink Navigation InstrumentsOLOSubstantially Equivalent
K230329F3D Interbody SystemODPSubstantially Equivalent
K230880CoreLink Navigation InstrumentsOLOSubstantially Equivalent
K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemOURSubstantially Equivalent
K221776NextGen Pedicle Screw SystemNKBSubstantially Equivalent
K220973CoreLink Navigation InstrumentsOLOSubstantially Equivalent
K211417F3D-C2 Cervical Stand-Alone SystemOVESubstantially Equivalent
K214059CoreLink Navigation InstrumentsOLOSubstantially Equivalent
K212825CoreLink Navigation InstrumentsOLOSubstantially Equivalent
K210539CoreLink Midline Fixation SystemNKBSubstantially Equivalent
K202637F3D Corpectomy SystemMQPSubstantially Equivalent
K200087F3D Cervical Stand-Alone Interbody Fusion SystemOVESubstantially Equivalent
K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemNKGSubstantially Equivalent
K182731Corelink Navigation InstrumentsOLOSubstantially Equivalent
K190016Lateral Plate SystemKWQSubstantially Equivalent
K183239CoreLink F3D™ Lateral SystemMAXSubstantially Equivalent
K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemOVDSubstantially Equivalent
K180556Corelink Foundation 3D Anterior Lumbar SystemMAXSubstantially Equivalent
K163104Terrace™ Anterior Cervical Plate SystemKWQSubstantially Equivalent
K162496Foundation 3D InterbodyODPSubstantially Equivalent
K152237The Entasis Dual-Lead Sacroiliac ImplantOURSubstantially Equivalent
K150847Foundation Interbody DevicesODPSubstantially Equivalent
K133369TIGER SPINE SYSTEMNKBSubstantially Equivalent
K132994ANODYNE ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMKWPSubstantially Equivalent
K131250TIGER SPINE SYSTEMNKBSubstantially Equivalent
K121514ANODYNE ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K121791ZOU ANTERIOR LUMBAR PLATE SYSTEMKWQSubstantially Equivalent
K121728TIGER SPINE SYSTEMNKBSubstantially Equivalent
K120696TIGER SPINE SYSTEMMNISubstantially Equivalent
K113058TIGER SPINE SYSTEMNKBSubstantially Equivalent
K110321TIGER SPINE SYSTEMMNHSubstantially Equivalent
K073440FOUNDATION CAGEMAXSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0954-2023CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.Class IITerminated

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