Halo Systems 522C

GUDID 05690977084254

SKULL PIN 2-1/4 CT 6 PK

OSSUR AMERICAS, INC.

Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring pin Cervical spine immobilization head ring rod Cervical spine immobilization head ring rod Cervical spine immobilization head ring rod Cervical spine immobilization head ring rod Cervical spine immobilization head ring rod Cervical spine immobilization head ring rod Cervical spine immobilization head ring rod Cervical spine immobilization head ring rod Cervical spine immobilization head ring rod Cervical spine immobilization head ring rod Cervical spine immobilization head ring rod Cervical spine immobilization head ring rod Cervical spine immobilization head ring rod

• Primary Device ID: 05690977084254
• NIH Device Record Key: 57df3a81-9a6a-4286-8bd4-b1000190f7ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halo Systems
• Version Model Number: 522C
• Catalog Number: 522C
• Company DUNS: 139280028
• Company Name: OSSUR AMERICAS, 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05690977084254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040363

FDA Product Code

• LYT: FIXATION ACCESSORY

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-16

On-Brand Devices [Halo Systems]

• 05690977370524: RESOLVE TRACTION HOOP ASSM
• 05690977368972: RESOLVE POSITION PINS & PADS
• 05690977368965: Skull Pin 2-1/4in CT Sterl 6PK
• 05690977368958: Skull Pin 3in TI Sterl 5 PK
• 05690977368941: Skull Pin 2-1/4in TI Sterl 5PK
• 05690977368934: Skull Pin 3in TI Sterl 1PK
• 05690977343306: CB RING TRAY LG
• 05690977343283: CB RING TRAY STD
• 05690977343269: CB RING TRAY SM
• 05690977334960: CB RING KIT TI SM-No App
• 05690977326200: CB RING KIT TI LG-No App
• 05690977319035: CB RING KIT TI STD-No App
• 05690977309357: Kit Closed Back Halo Lg
• 05690977309340: Kit Closed Back Halo Sm
• 05690977309333: Kit Closed Back Halo Md
• 05690977308718: J TONG SML/MED- No App
• 05690977308701: J TONG MED/LGE-No App
• 05690977308695: OB V2 RING KIT TI LG-No App
• 05690977308688: OB V2 RING KIT TI STD-No App
• 05690977308671: OB V2 RING KIT TI SM-No App
• 05690977308664: OB RESOLVE RING KIT LG-No App
• 05690977308657: OB RESOLVE RING KIT STD-No App
• 05690977308640: OB RESOLVE RING KIT SM-No App
• 05690977308633: CB RESOLVE RING KIT LG-No App
• 05690977308626: CB RESOLVE RING KIT STD-No App
• 05690977308596: CB RESOLVE RING KIT SM-No App
• 05690977307599: PRESET TORQUE SCREWDRIVER 8LB
• 05690977305922: OPEN BACK GLASS HALO STD
• 05690977305915: OPEN BACK GLASS HALO SM
• 05690977305908: CB RING KIT TI LG
• 05690977305892: CB RING KIT TI STD
• 05690977305885: CB RING KIT TI SM
• 05690977223370: OB V2 RING KIT TI LG
• 05690977197404: OB RESOLVE COMPONENT TRAY
• 05690977197336: OB RESOLVE STERILE UNIT LGE
• 05690977197329: OB RESOLVE STERILE UNIT STD
• 05690977197312: OB RESOLVE STERILE UNIT SML
• 05690977197305: J TONG ONLY SML/MED
• 05690977197299: J TONG ONLY MED/LGE
• 05690977197282: J TONG ASSEMBLY SML/MED
• 05690977197275: J TONG ASSEMBLY MED/LGE
• 05690977196636: HALO APPLICATION TRAY
• 05690977194090: Skull Pin 2-1/4in CT Sterl 1PK
• 05690977193192: RESOLVE TRACTION HOOP
• 05690977193123: J TONG COMPONENT TRAY
• 05690977192577: Skull Pin 3in CT Sterl 4 PK
• 05690977192348: STERILE V2 COMPONENT TRAY
• 05690977165335: RESOLVE HALO COMP TRAY
• 05690977164130: HALO RINGS LG
• 05690977164116: HALO RINGS MDIUM