K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

Intervertebral Fusion Device With Bone Graft, Cervical

K&J Consulting Corporation

The following data is part of a premarket notification filed by K&j Consulting Corporation with the FDA for K&j Iva (acif, Dlif, Plif, Tlif, Alif) Peek Cage.

Pre-market Notification Details

Device IDK212038
510k NumberK212038
Device Name:K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant K&J Consulting Corporation 2260 Glenview Dr Lansdale,  PA  19446
ContactBarry E. Sands
CorrespondentBarry E. Sands
RQMIS Inc. 110 Haverhill Road Suite 524 Amesbury,  MA  01913
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-30
Decision Date2021-08-27

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