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

Knoxville, TN, US

Choice Spine LLC appears in FDA device records in Knoxville, TN. FDA records list 10 510(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
10
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 10 510(k) clearances for Choice Spine LLC between 2009 and 2023. The busiest year on record is 2021, with 3. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Choice Spine LLC, by decision year
YearClearances
20091
20192
20201
20213
20222
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemOVESubstantially Equivalent
K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemMAXSubstantially Equivalent
K220024ChoiceSpine Navigation SystemOLOSubstantially Equivalent
K211449Triton™ Sacroiliac Joint Fixation SystemOURSubstantially Equivalent
K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemOVESubstantially Equivalent
K203561ChoiceSpine Navigation SystemOLOSubstantially Equivalent
K201643ChoiceSpine Tiger Shark Cervical Spacer SystemODPSubstantially Equivalent
K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion SystemODPSubstantially Equivalent
K191367Harrier-SA Lumbar Interbody SystemMAXSubstantially Equivalent
K091531CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACERODPSubstantially Equivalent

Registered establishments

FDA registered establishments for Choice Spine LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30058194743005819474Choice Spine LLC400 Erin Dr, Knoxville, TN 37919 US2026and 10 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