3.5MM ACP (ACTIVE COMPRESSION PLATE)

Basic Information

• Brand Name: 3.5MM ACP (ACTIVE COMPRESSION PLATE)
• Primary DI: 00887868062889
• Version / Model: 8566-77-000
• Catalog Number: 856677000
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 5
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 44bf41c8-ced7-4f1a-a449-85a11efde135

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE	Orthopedic	888.3030	2
HWC	Screw, fixation, bone	Orthopedic	888.3040	2
HTY	PIN, FIXATION, SMOOTH	Orthopedic	888.3040	2
JDW	PIN, FIXATION, THREADED	Orthopedic	888.3040	2
HRS	PLATE, FIXATION, BONE	Orthopedic	888.3030	2
KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT	Orthopedic	888.3030	2
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES	Orthopedic	888.3020	2
HTN	WASHER, BOLT NUT	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46647	Orthopaedic fixation plate, non-bioabsorbable	A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887868062889	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			7 HOLE