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

Maitland, FL, US

SpineNet LLC appears in FDA device records in Maitland, FL. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for SpineNet LLC between 2011 and 2020. The busiest year on record is 2011, with 1. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for SpineNet LLC, by decision year
YearClearances
20111
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200170SpineNet SSP SystemKWQSubstantially Equivalent
K110733DAYTONA ANTERIOR CERVICAL CAGEODPSubstantially Equivalent

Registered establishments

FDA registered establishments for SpineNet LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30067556263006755626SpineNet LLC901 N. Lake Destiny Rd, Maitland, FL 32751 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-2103-2013SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc levelThe recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.Class IITerminated
Z-2107-2013SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.Class IITerminated

Verification record

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