Alpine

Basic Information

• Brand Name: Alpine
• Primary DI: 00822409018802
• Version / Model: 700-0308
• Company Name: Ortho Development Corporation
• Labeler DUNS: 876542390
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-11
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0c5eca89-816a-414a-9fd5-7d13b1c511e2

Device Description

Alpine Centralizer 8 mm

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: Yes
• 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
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	Orthopedic	888.3390	2
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous	Orthopedic	888.3358	2
KWL	Prosthesis, hip, hemi-, femoral, metal	Orthopedic	888.3360	2
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	Orthopedic	888.3353	2
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33181	Metal-on-polyethylene total hip prosthesis	A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00822409018802	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153216	000