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

Westmont, IL, US

SPINECRAFT LLC appears in FDA device records in Westmont, IL. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
18
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for Spinecraft LLC between 2006 and 2026. The busiest year on record is 2006, with 2. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Spinecraft LLC, by decision year
YearClearances
20062
20091
20102
20112
20132
20152
20181
20212
20221
20231
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253260ORIO-3D Cage SystemODPSubstantially Equivalent
K260015ANTERIS Thoracolumbar Plate SystemKWQSubstantially Equivalent
K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemOLOSubstantially Equivalent
K223273ASTRA Spine SystemNKBSubstantially Equivalent
K211935ORIO-Ti Intervertebral Body Fusion Cage SystemODPSubstantially Equivalent
K211323ASTRA Spine SystemNKBSubstantially Equivalent
K181350ASTRA-OCT Spine SystemNKGSubstantially Equivalent
K143683APEX-DL Spine SystemNKBSubstantially Equivalent
K150417ASTRA SPINE SYSTEMNKBSubstantially Equivalent
K131521VELOX ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K132603APEX SPINE SYSTEMNKBSubstantially Equivalent
K110906APEX SPINE SYSTEMNKBSubstantially Equivalent
K103505ALTUM ANTERIOR CERVICAL PLATEKWQSubstantially Equivalent
K102488APEX SPINE SYSTEM W/ COCR RODSMNHSubstantially Equivalent
K092825APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHERKWPSubstantially Equivalent
K090887ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGESODPSubstantially Equivalent
K062513APEX SPINE SYSTEMKWPSubstantially Equivalent
K062496OSTEOPORE TCPMQVSubstantially Equivalent

Registered establishments

FDA registered establishments for Spinecraft LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30047173583004717358SPINECRAFT LLC777 Oakmont Ln Suite 200, Westmont, IL 60559 US2026and 2 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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