LFIT 06-4497

GUDID 07613327032864

Femoral Head

Howmedica Osteonics Corp.

Metallic femoral head prosthesis

• Primary Device ID: 07613327032864
• NIH Device Record Key: ece7f9c0-83e9-43db-81f7-5e803038e65b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LFIT
• Version Model Number: 06-4497
• Catalog Number: 06-4497
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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: false
• 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 Dimensions

• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 44 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327032864 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061434

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2015-09-24

On-Brand Devices [LFIT]

• 07613327072389: Femoral Head
• 07613327072372: Femoral Head
• 07613327072365: Femoral Head
• 07613327072358: Femoral Head
• 07613327032895: V40 Femoral Head
• 07613327032888: V40 Femoral Head
• 07613327032871: V40 Femoral Head
• 07613327032864: Femoral Head
• 07613327032857: Femoral Head
• 07613327032840: Femoral Head
• 07613327032833: Femoral Head
• 07613327032826: Femoral Head
• 07613327032819: Femoral Head
• 07613327032802: V40 Femoral Head
• 07613327032796: Femoral Head
• 07613327032789: V40 Femoral Head
• 07613327032772: V40 Femoral Head
• 07613327032765: V40 Femoral Head
• 07613327032758: V40 Femoral Head
• 07613327032741: V40 Femoral Head
• 07613327032734: V40 Femoral Head
• 07613327032727: V40 Femoral Head
• 07613327032710: V40 Femoral Head
• 07613327032703: V40 Femoral Head
• 07613327032697: Femoral Head
• 07613327032680: Femoral Head
• 07613327032673: Femoral Head
• 07613327032666: Femoral Head
• 07613327032659: Femoral Head
• 07613327032642: Femoral Head
• 07613327032635: Femoral Head
• 07613327032628: Femoral Head
• 07613327032611: Femoral Head
• 07613327032604: Femoral Head
• 07613327032321: V40 Femoral Head
• 07613327032314: V40 Femoral Head
• 07613327032307: V40 Femoral Head
• 07613327032291: V40 Femoral Head