PHYSICA Instrument Set 9065.22.611

GUDID 08033390104340

H11mm Extension Spacer

LIMACORPORATE SPA

Knee tibia prosthesis trial, reusable

• Primary Device ID: 08033390104340
• NIH Device Record Key: f3bf41e1-de35-4fc9-9648-23a56860725f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHYSICA Instrument Set
• Version Model Number: Extension Spacer
• Catalog Number: 9065.22.611
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: false
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390104340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141934

FDA Product Code

• HRY: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

[08033390104340]

Moist Heat or Steam Sterilization

[08033390104340]

Moist Heat or Steam Sterilization

[08033390104340]

Moist Heat or Steam Sterilization

[08033390104340]

Moist Heat or Steam Sterilization

[08033390104340]

Moist Heat or Steam Sterilization

[08033390104340]

Moist Heat or Steam Sterilization

[08033390104340]

Moist Heat or Steam Sterilization

[08033390104340]

Moist Heat or Steam Sterilization

[08033390104340]

Moist Heat or Steam Sterilization

[08033390104340]

Moist Heat or Steam Sterilization

[08033390104340]

Moist Heat or Steam Sterilization

[08033390104340]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-03-22
• Device Publish Date: 2016-06-07

On-Brand Devices [PHYSICA Instrument Set]

• 08033390103572: Femoral Trial/PS Box Guide Inserter/Extractor
• 08033390099752: Femoral Peg Inserter
• 08033390097956: Femoral Positioner Inserter/Extractor
• 08033390097666: Tibial Positioner Inserter/Extractor
• 08033390110464: Trial Patella D.32mm h.8.5mm
• 08033390110457: Trial Patella D.29mm h.7mm
• 08033390110440: Trial Patella D.26mm h.7mm
• 08033390093576: Guide Tibial Winged Broach-#9-#10
• 08033390093569: Guide Tibial Winged Broach-#1-#2
• 08033390090513: Guide Tibial Winged Broach-#6-#7-#8
• 08033390090506: Guide Tibial Winged Broach-#3-#4-#5
• 08033390090933: Tibial Reamer
• 08033390107990: Extension Spacer H10mm
• 08033390107983: Trial Tibial Plate #10
• 08033390107976: Trial Tibial Plate #9
• 08033390107969: Trial Tibial Plate #8
• 08033390107952: Trial Tibial Plate #7
• 08033390107945: Trial Tibial Plate #6
• 08033390107938: Trial Tibial Plate #5
• 08033390107921: Trial Tibial Plate #4
• 08033390107914: Trial Tibial Plate #3
• 08033390107907: Trial Tibial Plate #2
• 08033390107891: Trial Tibial Plate #1
• 08033390104371: H16mm Extension Spacer
• 08033390104364: H14mm Extension Spacer
• 08033390104357: H12mm Extension Spacer
• 08033390104340: H11mm Extension Spacer
• 08033390104333: H10mm Extension Spacer
• 08033390097505: PS Trial Liner #10 - H.20mm
• 08033390097499: PS Trial Liner #9 - H.20mm
• 08033390097482: PS Trial Liner #8 - H.20mm
• 08033390097475: PS Trial Liner #7 - H.20mm
• 08033390097468: PS Trial Liner #6 - H.20mm
• 08033390097451: PS Trial Liner #5 - H.20mm
• 08033390097444: PS Trial Liner #4 - H.20mm
• 08033390097437: PS Trial Liner #3 - H.20mm
• 08033390097420: PS Trial Liner #2 - H.20mm
• 08033390097413: PS Trial Liner #1 - H.20mm
• 08033390097406: PS Trial Liner #10 - H.16mm
• 08033390097390: PS Trial Liner #9 - H.16mm
• 08033390097383: PS Trial Liner #8 - H.16mm
• 08033390097376: PS Trial Liner #7 - H.16mm
• 08033390097369: PS Trial Liner #6 - H.16mm
• 08033390097352: PS Trial Liner #5 - H.16mm
• 08033390097345: PS Trial Liner #4 - H.16mm
• 08033390097338: PS Trial Liner #3 - H.16mm
• 08033390097321: PS Trial Liner #2 - H.16mm
• 08033390097314: PS Trial Liner #1 - H.16mm
• 08033390097307: PS Trial Liner #10 - H.14mm
• 08033390097291: PS Trial Liner #9 - H.14mm