AOS SPACER, STATIC LOCKING TIBIAL NAIL

GUDID 00848665005363

ADVANCED ORTHOPEDIC SOLUTIONS INC

Bone nail end-cap, sterile Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap

• Primary Device ID: 00848665005363
• NIH Device Record Key: 5f38fe2e-f2a8-4a8c-abac-9894c45ec79c
• Commercial Distribution Discontinuation: 2017-06-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AOS SPACER, STATIC LOCKING TIBIAL NAIL
• Version Model Number: S1117
• Company DUNS: 117858154
• Company Name: ADVANCED ORTHOPEDIC SOLUTIONS 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665005363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070444

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

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: 2018-10-22
• Device Publish Date: 2015-10-14

On-Brand Devices [AOS SPACER, STATIC LOCKING TIBIAL NAIL]

• 00848665016567: 1117
• 00848665005363: S1117