Exact Osteotomy System

GUDID B562OGSCA550

EXACT OSTEOTOMY SYSTEM - CHEVRON/AUSTIN (55 DEGREE)

WISHBONE MEDICAL, INC.

Osteotomy guide, single-use

• Primary Device ID: B562OGSCA550
• NIH Device Record Key: c1ae0f4a-cced-4bd5-afb1-ae22f0a37db1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exact Osteotomy System
• Version Model Number: OGS-CA55
• Company DUNS: 062355158
• Company Name: WISHBONE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
HIBCC	B562OGSCA550 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-24
• Device Publish Date: 2021-09-16

On-Brand Devices [Exact Osteotomy System]

• B562OGSYWG30: EXACT OSTEOTOMY SYSTEM - YOUNGWICK GUIDE (3MM)
• B562OGSYWG20: EXACT OSTEOTOMY SYSTEM - YOUNGWICK GUIDE (2MM)
• B562OGSYWG10: EXACT OSTEOTOMY SYSTEM - YOUNGWICK GUIDE (1MM)
• B562OGSSCZG0: EXACT OSTEOTOMY SYSTEM - SCARF Z GUIDE
• B562OGSPDG20: EXACT OSTEOTOMY SYSTEM - PASA/DMAA (2-STAGE GUIDE)
• B562OGSLA450: EXACT OSTEOTOMY SYSTEM - LONG ARM GUIDE (45-DEGREE)
• B562OGSDMAA0: EXACT OSTEOTOMY SYSTEM - DMAA GUIDE
• B562OGSCA550: EXACT OSTEOTOMY SYSTEM - CHEVRON/AUSTIN (55 DEGREE)