ACUMED PELVIC BONE PLATE SYSTEM

Plate, Fixation, Bone

ACUMED LLC

The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Pelvic Bone Plate System.

Pre-market Notification Details

Device IDK122538
510k NumberK122538
Device Name:ACUMED PELVIC BONE PLATE SYSTEM
ClassificationPlate, Fixation, Bone
Applicant ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro,  OR  97124
ContactKara Budor
CorrespondentKara Budor
ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro,  OR  97124
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-21
Decision Date2012-11-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10806378088605 K122538 000
10806378048456 K122538 000
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10806378048432 K122538 000
10806378048425 K122538 000
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10806378088568 K122538 000
10806378088551 K122538 000
10806378048463 K122538 000
10806378048470 K122538 000
10806378048487 K122538 000
10806378088599 K122538 000
10806378088582 K122538 000
10806378088575 K122538 000
10806378048531 K122538 000
10806378048524 K122538 000
10806378048517 K122538 000
10806378048500 K122538 000
10806378048494 K122538 000
10806378035890 K122538 000

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