NATURAL BRIDGE LP TRANSVERSE CONNECTORS

Orthosis, Spinal Pedicle Fixation

K2M, INC.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Natural Bridge Lp Transverse Connectors.

Pre-market Notification Details

Device IDK072914
510k NumberK072914
Device Name:NATURAL BRIDGE LP TRANSVERSE CONNECTORS
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant K2M, INC. 751 MILLER DR.,SE Leesburg,  VA  20175
ContactRichard W Woods
CorrespondentRichard W Woods
K2M, INC. 751 MILLER DR.,SE Leesburg,  VA  20175
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-12
Decision Date2008-01-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888857142602 K072914 000
10888857141445 K072914 000
10888857141483 K072914 000
10888857141544 K072914 000
10888857141582 K072914 000
10888857141629 K072914 000
10888857141643 K072914 000
10888857141742 K072914 000
10888857141889 K072914 000
10888857141940 K072914 000
10888857141407 K072914 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.