PG 2016-03

GUDID 04042409062810

Mini Plate 2.0, 3 round holes, L 17

aap Implantate AG

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

Primary Device ID	04042409062810
NIH Device Record Key	3fbf46fa-9b11-4568-83d5-32b43a1e5b51
Commercial Distribution Status	In Commercial Distribution
Version Model Number	PG 2016-03
Catalog Number	PG 2016-03
Company DUNS	328420633
Company Name	aap Implantate AG
Device Count	1
DM Exempt	true
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04042409062810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K072411

FDA Product Code

HRS	Plate, fixation, bone