101-13-04

GUDID 10885862010896

Calcar Planar Large

Exactech, Inc.

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Primary Device ID	10885862010896
NIH Device Record Key	9973b66d-f317-4e5b-b64f-7cd8de8655f7
Commercial Distribution Status	In Commercial Distribution
Version Model Number	101-13-04
Catalog Number	101-13-04
Company DUNS	157565946
Company Name	Exactech, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862010896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K041906

FDA Product Code

LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented