Actinia®

GUDID 04048844152796

hip stem cementless standard

implantcast GmbH

Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis

• Primary Device ID: 04048844152796
• NIH Device Record Key: ea822817-a3c6-49b2-9b85-12d0ca1fc05d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Actinia®
• Version Model Number: 80040008
• Company DUNS: 324369826
• Company Name: implantcast GmbH
• 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

• 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 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	04048844152796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232371

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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: 2023-11-01
• Device Publish Date: 2023-10-24

On-Brand Devices [Actinia®]

• 04048844499112: trial neck snap coxa vara
• 04048844376291: trial neck snap lat.
• 04048844376284: trial neck snap std.
• 04048844486839: broach handle easy lock double offset left
• 04048844486822: broach handle easy lock double offset right
• 04048844486815: broach handle easy lock GIS® left
• 04048844486808: broach handle easy lock GIS® right
• 04048844441692: hip stem coxa vara cementless standard
• 04048844441685: hip stem coxa vara cementless standard
• 04048844441678: hip stem coxa vara cementless standard
• 04048844441661: hip stem coxa vara cementless standard
• 04048844441654: hip stem coxa vara cementless standard
• 04048844441647: hip stem coxa vara cementless standard
• 04048844441630: hip stem coxa vara cementless standard
• 04048844441623: hip stem coxa vara cementless standard
• 04048844441616: hip stem coxa vara cementless standard
• 04048844196646: broach
• 04048844196639: broach
• 04048844196615: broach
• 04048844196608: broach
• 04048844196592: broach
• 04048844196585: broach
• 04048844196578: broach
• 04048844196561: broach
• 04048844196554: broach
• 04048844196547: broach
• 04048844196530: broach
• 04048844174071: hip stem cementless lateralized
• 04048844153502: hip stem with collar cementless standard
• 04048844153496: hip stem with collar cementless standard
• 04048844153489: hip stem with collar cementless standard
• 04048844153472: hip stem with collar cementless standard
• 04048844153465: hip stem with collar cementless standard
• 04048844153458: hip stem with collar cementless standard
• 04048844153441: hip stem with collar cementless standard
• 04048844153434: hip stem with collar cementless standard
• 04048844153427: hip stem with collar cementless standard
• 04048844153410: hip stem with collar cementless standard
• 04048844153403: hip stem with collar cementless standard
• 04048844153380: hip stem with collar cementless lateralized
• 04048844153373: hip stem with collar cementless lateralized
• 04048844153366: hip stem with collar cementless lateralized
• 04048844153359: hip stem with collar cementless lateralized
• 04048844153342: hip stem with collar cementless lateralized
• 04048844153335: hip stem with collar cementless lateralized
• 04048844153328: hip stem with collar cementless lateralized
• 04048844153311: hip stem with collar cementless lateralized
• 04048844153304: hip stem with collar cementless lateralized
• 04048844153298: hip stem with collar cementless lateralized
• 04048844152857: hip stem cementless standard