Summa Orthopaedics System Bone Screw

GUDID 08806390868198

Jeil Medical Corporation

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 08806390868198
• NIH Device Record Key: aff8f7c9-93ed-4b72-9a0a-0ce7d145b1f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics System Bone Screw
• Version Model Number: SO-15L-HF-012
• Company DUNS: 688811603
• Company Name: Jeil Medical Corporation
• 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	08806390868198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161746

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[08806390868198]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2018-04-30

On-Brand Devices [Summa Orthopaedics System Bone Screw]

• 08806390869317: SO-25-HF-030
• 08806390869300: SO-25-HF-028
• 08806390869294: SO-25-HF-026
• 08806390869287: SO-25-HF-024
• 08806390869270: SO-25-HF-022
• 08806390869263: SO-25-HF-020
• 08806390869256: SO-25-HF-018
• 08806390869249: SO-25-HF-016
• 08806390869232: SO-25-HF-014
• 08806390869225: SO-25-HF-012
• 08806390869218: SO-25-HF-010
• 08806390869201: SO-25-HF-008
• 08806390869195: SO-161.032530
• 08806390869188: SO-161.032528
• 08806390869171: SO-161.032526
• 08806390869164: SO-161.032524
• 08806390869157: SO-161.032522
• 08806390869140: SO-161.032520
• 08806390869133: SO-161.032518
• 08806390869126: SO-161.032516
• 08806390869119: SO-161.032514
• 08806390869102: SO-161.032512
• 08806390869096: SO-161.032510
• 08806390869089: SO-161.032508
• 08806390883641: 40_WASHER_Ø7.0
• 08806390883634: 40_NON_CANNULATED_NOR_STARIX_70MM
• 08806390883610: 40_NON_CANNULATED_NOR_STARIX_62MM
• 08806390883603: 40_NON_CANNULATED_NOR_STARIX_58MM
• 08806390883597: 40_NON_CANNULATED_NOR_STARIX_54MM
• 08806390883580: 40_NON_CANNULATED_NOR_STARIX_50MM
• 08806390883573: 40_NON_CANNULATED_NOR_STARIX_46MM
• 08806390883566: 40_NON_CANNULATED_NOR_STARIX_42MM
• 08806390883559: 40_NON_CANNULATED_NOR_STARIX_38MM
• 08806390883542: 40_NON_CANNULATED_NOR_STARIX_34MM
• 08806390883535: 40_NON_CANNULATED_NOR_STARIX_30MM
• 08806390883528: 40_NON_CANNULATED_NOR_STARIX_28MM
• 08806390883511: 40_NON_CANNULATED_NOR_STARIX_26MM
• 08806390883504: 40_NON_CANNULATED_NOR_STARIX_24MM
• 08806390883498: 40_NON_CANNULATED_NOR_STARIX_22MM
• 08806390883481: 40_NON_CANNULATED_NOR_STARIX_20MM
• 08806390865838: SO-111-069-2
• 08806390865821: SO-111-069-1
• 08806390874854: SO-25L-SO-026-TA
• 08806390868198: SO-15L-HF-012
• 08806390868174: SO-15L-HF-010
• 08806390868150: SO-15L-HF-008
• 08806390867993: SO-25-SO-024-TA
• 08806390867986: SO-25-SO-022-TA
• 08806390867979: SO-25-SO-020-TA
• 08806390867962: SO-25-SO-018-TA