iNSitu™ Hip System

GUDID 00816127023125

Acetabular Bone Screw, 6.5mm x 60mm

NEXTSTEP ARTHROPEDIX, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00816127023125
• NIH Device Record Key: 72e53038-46e9-4126-8756-fd3d9853569d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iNSitu™ Hip System
• Version Model Number: 10-60-6560
• Company DUNS: 060211165
• Company Name: NEXTSTEP ARTHROPEDIX, LLC
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816127023125 [Primary]

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2024-02-19
• Device Publish Date: 2023-09-12

On-Brand Devices [iNSitu™ Hip System]

• 00816127020032: Femoral Broach Size 2
• 00816127020025: Femoral Broach Size 1
• 00810030811664: Straight Broach Handle, Lever Action
• 00810030811572: Preoperative Template, Acetabular Cups Assembly
• 00810030811565: Preoperative Template, Femoral Stems Assembly
• 00810030810360: Broach Handle, Straight, Kickstand
• 00816127020643: Head Trial 40mm x +10mm
• 00816127020636: Head Trial 40mm x +8mm
• 00816127020629: Head Trial 40mm x +4mm
• 00816127020612: Head Trial 40mm x +0mm
• 00816127020605: Head Trial 40mm x -4mm
• 00816127020599: Head Trial 36mm x +10mm
• 00816127020582: Head Trial 36mm x +8mm
• 00816127020575: Head Trial 36mm x +4mm
• 00816127020568: Head Trial 36mm x +0mm
• 00816127020551: Head Trial 36mm x -4mm
• 00816127020544: Head Trial 32mm x +10mm
• 00816127020537: Head Trial 32mm x +7mm
• 00816127020520: Head Trial 32mm x +4mm
• 00816127020513: Head Trial 32mm x +0mm
• 00816127020506: Head Trial 32mm x -4mm
• 00816127020490: Head Trial 28mm x +7mm
• 00816127020483: Head Trial 28mm x +3.5mm
• 00816127020476: Head Trial 28mm x +0mm
• 00816127020452: Neck Trial, Size 14, Lateral
• 00816127020445: Neck Trial, Size 13, Lateral
• 00816127020438: Neck Trial, Size 12, Lateral
• 00816127020421: Neck Trial, Size 11, Lateral
• 00816127020414: Neck Trial, Size 10, Lateral
• 00816127020407: Neck Trial, Size 9, Lateral
• 00816127020391: Neck Trial, Size 8, Lateral
• 00816127020384: Neck Trial, Size 7, Lateral
• 00816127020377: Neck Trial, Size 6, Lateral
• 00816127020360: Neck Trial, Size 5, Lateral
• 00816127020353: Neck Trial, Size 4, Lateral
• 00816127020346: Neck Trial, Size 3, Lateral
• 00816127020339: Neck Trial, Size 2, Lateral
• 00816127020322: Neck Trial, Size 1, Lateral
• 00816127020315: Neck Trial, Size 0, Lateral
• 00816127020308: Neck Trial, Size 14, Standard
• 00816127020292: Neck Trial, Size 13, Standard
• 00816127020285: Neck Trial, Size 12, Standard
• 00816127020278: Neck Trial, Size 11, Standard
• 00816127020261: Neck Trial, Size 10, Standard
• 00816127020254: Neck Trial, Size 9, Standard
• 00816127020247: Neck Trial, Size 8, Standard
• 00816127020230: Neck Trial, Size 7, Standard
• 00816127020223: Neck Trial, Size 6, Standard
• 00816127020216: Neck Trial, Size 5, Standard
• 00816127020209: Neck Trial, Size 4, Standard