InSitu Hip System 10-21-2802

GUDID 00816127022432

Femoral Head, 28mm, +3.5mm, Biolox

NEXTSTEP ARTHROPEDIX, LLC

Ceramic femoral head prosthesis

• Primary Device ID: 00816127022432
• NIH Device Record Key: ba4d35c4-3588-401c-8092-241a4857f897
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InSitu Hip System
• Version Model Number: 10-21-2802
• Catalog Number: 10-21-2802
• Company DUNS: 060211165
• Company Name: NEXTSTEP ARTHROPEDIX, LLC
• 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: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816127022432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161184

FDA Product Code

• OQI: Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-15

On-Brand Devices [InSitu Hip System]

• 00816127024115: Femoral Head, 40mm, +10.5mm, CoCr Skirted
• 00816127024078: Femoral Stem, Size 0, Lateralized
• 00816127024061: Femoral Stem, Size 0, Standard
• 00816127023774: Acetabular Cup, Size 68, Solid Anodized
• 00816127023767: Acetabular Cup, Size 66, Solid Anodized
• 00816127023750: Acetabular Cup, Size 64, Solid Anodized
• 00816127023743: Acetabular Cup, Size 62, Solid Anodized
• 00816127023736: Acetabular Cup, Size 60, Solid Anodized
• 00816127023729: Acetabular Cup, Size 58, Solid Anodized
• 00816127023712: Acetabular Cup, Size 56, Solid Anodized
• 00816127023705: Acetabular Cup, Size 54, Solid Anodized
• 00816127023699: Acetabular Cup, Size 52, Solid Anodized
• 00816127023682: Acetabular Cup, Size 50, Solid Anodized
• 00816127023675: Acetabular Cup, Size 48, Solid Anodized
• 00816127023668: Acetabular Cup, Size 46, Solid Anodized
• 00816127022753: Acetabular Liner, Size 54/56 x 36mm ID , Neutral
• 00816127022746: Acetabular Liner, Size 52 x 36mm ID, Neutral
• 00816127022739: Acetabular Liner, Size 50 x 36mm ID, Neutral
• 00816127022722: Acetabular Liner, Size 48 x 32mm ID, Neutral
• 00816127022715: Acetabular Liner, Size 46 x 32mm ID, Neutral
• 00816127022708: Acetabular Liner, Size 42/44 x 28mm ID, Neutral
• 00816127022692: Acetabular Cup, Size 44, Solid, Anodized
• 00816127022685: Acetabular Cup, Size 42, Solid, Anodized
• 00816127022678: Acetabular Cup, Size 68, Holed, Anodized
• 00816127022661: Acetabular Cup, Size 66, Holed, Anodized
• 00816127022654: Acetabular Cup, Size 64, Holed, Anodized
• 00816127022647: Acetabular Cup, Size 62, Holed, Anodized
• 00816127022630: Acetabular Cup, Size 60, Holed, Anodized
• 00816127022623: Acetabular Cup, Size 58, Holed, Anodized
• 00816127022616: Acetabular Cup, Size 56, Holed, Anodized
• 00816127022609: Acetabular Cup, Size 54, Holed, Anodized
• 00816127022593: Acetabular Cup, Size 52, Holed, Anodized
• 00816127022586: Acetabular Cup, Size 50, Holed, Anodized
• 00816127022579: Acetabular Cup, Size 48, Holed, Anodized
• 00816127022562: Acetabular Cup, Size 46, Holed, Anodized
• 00816127022555: Femoral Head, 40mm, +8mm, Biolox
• 00816127022548: Femoral Head, 40mm, +4mm, Biolox
• 00816127022531: Femoral Head, 40mm, 0mm, Biolox
• 00816127022524: Femoral Head, 40mm, -4mm, Biolox
• 00816127022517: Femoral Head, 36mm, +8mm, Biolox
• 00816127022500: Femoral Head, 36mm, +4mm, Biolox
• 00816127022494: Femoral Head, 36mm, 0mm, Biolox
• 00816127022487: Femoral Head, 36mm, -4mm, Biolox
• 00816127022470: Femoral Head, 32mm, +7mm, Biolox
• 00816127022463: Femoral Head, 32mm, +4mm, Biolox
• 00816127022456: Femoral Head, 32mm, 0mm, Biolox
• 00816127022449: Femoral Head, 32mm, -4mm, Biolox
• 00816127022432: Femoral Head, 28mm, +3.5mm, Biolox
• 00816127022425: Femoral Head, 28mm, 0mm, Biolox
• 00816127022418: Femoral Head, 28mm, -3.5mm, Biolox