SYNOVO HIP SYSTEM 01-03-0049

GUDID 00814193025654

HIP FEMORAL RESURFACING CUP - 49MM

Synovo Production

Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis Resurfacing metallic hip prosthesis

• Primary Device ID: 00814193025654
• NIH Device Record Key: 849eb948-bfec-4624-b238-305abcb05178
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNOVO HIP SYSTEM
• Version Model Number: 01-03-0049
• Catalog Number: 01-03-0049
• Company DUNS: 061486164
• Company Name: Synovo Production
• 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 Dimensions

• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter
• Outer Diameter: 49 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814193025654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904870

FDA Product Code

• KXA: Prosthesis, Hip, Femoral, Resurfacing

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: 2024-03-11
• Device Publish Date: 2024-03-02

On-Brand Devices [SYNOVO HIP SYSTEM]

• 00814193025753: HIP FEMORAL RESURFACING CUP -52.5 MM
• 00814193025746: HIP FEMORAL RESURFACING CUP - 36.5 MM
• 00814193025739: HIP FEMORAL RESURFACING CUP - 38MM
• 00814193025722: HIP FEMORAL RESURFACING CUP 39.5MM
• 00814193025715: HIP FEMORAL RESURFACING CUP 41MM
• 00814193025708: HIP FEMORAL RESURFACING CUP - 42.5MM
• 00814193025692: HIP FEMORAL RESURFACING CUP - 45.5 MM
• 00814193025685: HIP FEMORAL RESURFACING CUP - 47 MM
• 00814193025678: HIP FEMORAL RESURFACING CUP - 44MM
• 00814193025661: HIP FEMORAL RESURFACING CUP - 51MM
• 00814193025654: HIP FEMORAL RESURFACING CUP - 49MM
• 00814193025968: HIP ACETABULAR BEARING - 49 MM I.D. X 62 MM O.D.
• 00814193025951: HIP ACETABULAR BEARING - 52.5 MM I.D. X 66 TO 70 MM O.D.
• 00814193025944: HIP ACETABULAR BEARING - 51 MM I.D. X 64 MM O.D.
• 00814193025937: HIP ACETABULAR BEARING - 47 MM I.D. X 60 MM O.D.
• 00814193025920: HIP ACETABULAR BEARING - 45.5 MM I.D. X 58 MM O.D.
• 00814193025913: HIP ACETABULAR BEARING - 44 MM I.D. X 56 MM O.D.
• 00814193025906: HIP ACETABULAR BEARING - 42.5 MM I.D. X 54 MM O.D.
• 00814193025890: HIP ACETABULAR BEARING - 41 MM I.D. X 52 MM O.D.
• 00814193025883: HIP ACETABULAR FIXATION CUP - 70 MM 5 HOLE
• 00814193025876: HIP ACETABULAR FIXATION CUP - 68 MM 5 HOLE
• 00814193025869: HIP ACETABULAR FIXATION CUP - 66 MM 5 HOLE
• 00814193025852: HIP ACETABULAR FIXATION CUP - 64 MM 5 HOLE
• 00814193025845: HIP ACETABULAR FIXATION CUP - 62 MM 5 HOLE
• 00814193025838: HIP ACETABULAR FIXATION CUP - 60 MM 5 HOLE
• 00814193025821: HIP ACETABULAR FIXATION CUP - 58 MM 5 HOLE
• 00814193025814: HIP ACETABULAR FIXATION CUP - 56 MM 5 HOLE
• 00814193025807: HIP ACETABULAR FIXATION CUP - 54 MM 5 HOLE
• 00814193025791: HIP ACETABULAR FIXATION CUP - 52 MM 5 HOLE
• 00814193025784: HIP ACETABULAR FIXATION CUP - 50 MM 5 HOLE
• 00814193025777: HIP ACETABULAR FIXATION CUP - 48 MM 5 HOLE
• 00814193025760: HIP ACETABULAR FIXATION CUP - 46 MM 5 HOLE