PG 3513-07-2

GUDID 04042409063510

1/3 Tubular Plate 3.5, 7 round holes, L 89

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	04042409063510
NIH Device Record Key	7be289a2-d094-418b-8afb-47d0437df7cb
Commercial Distribution Status	In Commercial Distribution
Version Model Number	PG 3513-07-2
Catalog Number	PG 3513-07-2
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	04042409063510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K072411

FDA Product Code

HRS	Plate, fixation, bone