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

Overland Park, KS, US

SPINAL SIMPLICITY, LLC appears in FDA device records in Overland Park, KS. FDA records list 16 510(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
16
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 16 510(k) clearances for Spinal Simplicity, LLC between 2015 and 2026. The busiest year on record is 2023, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Spinal Simplicity, LLC, by decision year
YearClearances
20152
20171
20201
20211
20222
20233
20243
20252
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253523Freedom DS™ Decompression SystemHRXSubstantially Equivalent
K253250Minuteman® G6 MIS Fusion PlatePEKSubstantially Equivalent
K250001Patriot SI Implant SystemOURSubstantially Equivalent
K240592Wolff's Law Anterior Cervical Plate SystemKWQSubstantially Equivalent
K232259Patriot-SI Posterior Implant SystemOURSubstantially Equivalent
K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3PEKSubstantially Equivalent
K231923Liberty SI Lateral Implant SystemOURSubstantially Equivalent
K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion PlatePEKSubstantially Equivalent
K221307Edge Upper Cervical SystemNKGSubstantially Equivalent
K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5PEKSubstantially Equivalent
K211880Minuteman G5 MIS Fusion PlatePEKSubstantially Equivalent
K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion PlatePEKSubstantially Equivalent
K200066Posterior Fusion Plate, HA Posterior Fusion PlatePEKSubstantially Equivalent
K163428HA Minuteman G3-R MIS Fusion PlatePEKSubstantially Equivalent
K151741HA Minuteman G3 MIS Fusion PlatePEKSubstantially Equivalent
K140046SPINOUS PROCESS FUSION (SPF) PLATEPEKSubstantially Equivalent

Registered establishments

FDA registered establishments for Spinal Simplicity, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30097043013009704301SPINAL SIMPLICITY, LLC6363 College Blvd, Overland Park, KS 66211 US2026

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