PATHWAY IVB/VBR

Intervertebral Fusion Device With Bone Graft, Cervical

CUSTOM SPINE, INC.

The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Pathway Ivb/vbr.

Pre-market Notification Details

Device IDK092904
510k NumberK092904
Device Name:PATHWAY IVB/VBR
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany,  NJ  07054
ContactSaad Attiyah
CorrespondentSaad Attiyah
CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany,  NJ  07054
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-21
Decision Date2009-12-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00840916112967 K092904 000
00840916112974 K092904 000
00840916112981 K092904 000
00840916112998 K092904 000
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00840916113018 K092904 000
00840916113025 K092904 000
00840916113032 K092904 000
00840916113049 K092904 000
00840916113056 K092904 000
00840916113063 K092904 000
00840916113070 K092904 000
00840916113087 K092904 000
00840916112943 K092904 000

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