Rhausler C-5354

GUDID 08500588270755

Semiconstrained Cervical Plate Ti, 54mm, 3LVL

Rhausler Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08500588270755
• NIH Device Record Key: 7054785f-cc2a-45c0-8ede-276ccd6bcc3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rhausler
• Version Model Number: C-5354
• Catalog Number: C-5354
• Company DUNS: 015811277
• Company Name: Rhausler Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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 Dimensions

• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08500588270755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042073

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[08500588270755]

Moist Heat or Steam Sterilization

[08500588270755]

Moist Heat or Steam Sterilization

[08500588270755]

Moist Heat or Steam Sterilization

[08500588270755]

Moist Heat or Steam Sterilization

[08500588270755]

Moist Heat or Steam Sterilization

[08500588270755]

Moist Heat or Steam Sterilization

[08500588270755]

Moist Heat or Steam Sterilization

[08500588270755]

Moist Heat or Steam Sterilization

[08500588270755]

Moist Heat or Steam Sterilization

[08500588270755]

Moist Heat or Steam Sterilization

[08500588270755]

Moist Heat or Steam Sterilization

[08500588270755]

Moist Heat or Steam Sterilization

[08500588270755]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-21
• Device Publish Date: 2024-03-13

On-Brand Devices [Rhausler]

• 08500591420536: MD DYNAMIC PLATE 66MM, 4 LVL
• 08500591420529: MD DYNAMIC PLATE 63MM, 4LVL
• 08500591420512: MD DYNAMIC PLATE 51MM, 3 LVL
• 08500591420499: PLAGE BONE GRAFT IMPACTOR TOOL
• 08500591420482: PLAGE DRILL GUIDE HOLDER
• 08500591420475: PLAGE HOLDER/IMPACTOR TOOL
• 08500591420468: PLAGE TRIAL 17X16X10MM, GOLD LRG
• 08500591420451: PLAGE TRIAL 17X16X9MM, VIOLET LRG
• 08500591420437: PLAGE TRIAL 17X16X7MM, COPPER LRG
• 08500591420420: PLAGE TRIAL 17X16X6MM, BLUE LRG
• 08500591420413: PLAGE TRIAL 17X16X5MM, SILVER LRG
• 08500591420406: PLAGE TRIAL 15X14X10MM, GOLD STD
• 08500591420383: PLAGE TRIAL 15X14X8MM, GREEN STD
• 08500591420369: PLAGE TRIAL 15X14X6MM, BLUE STD
• 08500591420352: PLAGE TRIAL 15X14X5MM, SILVER STD
• 08500591420321: PLAGE TRIALS 13X14X8MM GREEN SML
• 08500591420314: PLAGE TRIALS 13X14X7MM COPPER SML
• 08500591420291: PLAGE TRIALS 13X14X5MM SILVER SML
• 08500591420277: PLAGE RASP 17X16X9MM, VIOLET LRG
• 08500591420260: PLAGE RASP 17X16X8MM, GREEN LRG
• 08500591420253: PLAGE RASP 17X16X7MM, COPPER LRG
• 08500591420246: PLAGE RASP 17X16X6MM, BLUE LRG
• 08500591420222: PLAGE RASP 15X14X10MM, GOLD STD
• 08500591420215: PLAGE RASP 15X14X9MM, VIOLET STD
• 08500591420185: PLAGE RASP 15X14X6MM, BLUE STD
• 08500591420178: PLAGE RASP 15X14X5MM, SILVER STD
• 08500591420161: PLAGE SERRATED RASP 13X14X10MM GOLD SML
• 08500591420154: PLAGE SERRATED RASP 13X14X9MM VIOLET SML
• 08500591420130: PLAGE SERRATED RASP 13X14X7 COPPER SML
• 08500591420123: PLAGE SERRATED RASP 13X14X6MM BLUE SML
• 08500591420116: PLAGE SERRATED RASP 13X14X5MM SILVER SML
• 08500591420109: PLAGE DRILL GUIDE GOLD LRG 0 DEG
• 08500591420086: PLAGE DRILL GUIDE GREEN LRG 0 DEG
• 08500591420079: PLAGE DRILL GUIDE COPPER LRG 0 DEG
• 08500591420062: PLAGE DRILL GUIDE BLUE LRG 0 DEG
• 08500591420055: PLAGE DRILL GUIDE SILVER LRG 0 DEG
• 08500591420048: PLAGE DRILL GUIDE GOLD S-STD 0 DEG
• 08500591420024: PLAGE DRILL GUIDE GREEN S-STD 0 DEG
• 08500591420017: PLAGE DRILL GUIDE COPPER S-STD 0 DEG
• 08500591410995: PLAGE DRILL GUIDE SILVER S-STD 0 DEG
• 08500591410988: PLAGE LORDO 17X16X10MM GOLD LRG 0 DEG
• 08500591410971: PLAGE LORDO 17X16X9MM VIOLET LRG 0 DEG
• 08500591410957: PLAGE LORDO 17X16X7MM COPPER LRG 0 DEG
• 08500591410940: PLAGE LORDO 17X16X6MM BLUE LRG 0 DEG
• 08500591410933: PLAGE LORDO 17X16X5MM SILVER LRG 0 DEG
• 08500591410926: PLAGE LORDO 15X14X10MM GOLD STD 6 DEG
• 08500591410902: PLAGE LORDO 15X14X8MM GREEN STD 6 DEG
• 08500591410896: PLAGE LORDO 15X14X7MM COPPER STD 6 DEG
• 08500591410872: PLAGE LORDO 15X14X5MM SILVER STD 6 DEG
• 08500591410858: PLAGE LORDO 15X14X9MM VIOLET STD 0 DEG