MICROPORT PHA04428

GUDID M684PHA044281

Microport Orthopedics Inc.

Ceramic femoral head prosthesis

• Primary Device ID: M684PHA044281
• NIH Device Record Key: 7b5ec3c3-1168-443b-9466-bb8be9871895
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICROPORT
• Version Model Number: PHA04428
• Catalog Number: PHA04428
• Company DUNS: 079118736
• Company Name: Microport Orthopedics 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com

Device Dimensions

• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M684PHA044281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173776

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-09-09
• Device Publish Date: 2018-08-19

On-Brand Devices [MICROPORT]

• M684260136XXWD1: 260136XXWD
• M684260136XX1: 260136XX
• M684260136XSWD1: 260136XSWD
• M684260136XS1: 260136XS
• M684260136XLWD1: 260136XLWD
• M684260136XL1: 260136XL
• M684260136SHWD1: 260136SHWD
• M684260136SH1: 260136SH
• M684260136MDWD1: 260136MDWD
• M684260136MD1: 260136MD
• M684260136LGWD1: 260136LGWD
• M684260136LG1: 260136LG
• M68426010011WD1: 26010011WD
• M684260100111: 26010011
• M68426010006WD1: 26010006WD
• M684260100061: 26010006
• M684PHA044441: PHA04444
• M684PHA044401: PHA04440
• M684PHA044361: PHA04436
• M684PHA044321: PHA04432
• M684PHA044281: PHA04428
• M684PHA044261: PHA04426
• M684PHA044191: PHA04419
• M684PHA044131: PHA04413
• M6848400FD131: FLEX DRILL 3.2 X 25MM II ONE PIECE
• M684APA021431: FEMORAL HEAD TRIAL 40MM X-LONG
• M684ATBRHANL1: ANTERIOR BROACH HANDLE LEFT DOUBLE OFFSET
• M684ATBRHANR1: ANTERIOR BROACH HANDLE RIGHT DOUBLE OFFSET
• M684INLNBRHN1: INLINE BROACH HANDLE INSTRUMENT
• M684SPHXRM681: BASKET REAMER 68MM HEX
• M684SPHXRM671: BASKET REAMER 67MM HEX
• M684SPHXRM661: BASKET REAMER 66MM HEX
• M684SPHXRM651: BASKET REAMER 65MM HEX
• M684SPHXRM641: BASKET REAMER 64MM HEX
• M684SPHXRM631: BASKET REAMER 63MM HEX
• M684SPHXRM621: BASKET REAMER 62MM HEX
• M684SPHXRM611: BASKET REAMER 61MM HEX
• M684SPHXRM601: BASKET REAMER 60MM HEX
• M684SPHXRM591: BASKET REAMER 59MM HEX
• M684SPHXRM581: BASKET REAMER 58MM HEX
• M684SPHXRM571: BASKET REAMER 57MM HEX
• M684SPHXRM561: BASKET REAMER 56MM HEX
• M684SPHXRM551: BASKET REAMER 55MM HEX
• M684SPHXRM541: BASKET REAMER 54MM HEX
• M684SPHXRM531: BASKET REAMER 53MM HEX
• M684SPHXRM521: BASKET REAMER 52MM HEX