Actinia®

Primary DI
04048844196554
Brand
Actinia®
Company
implantcast GmbH
Model
80049010
Device description
broach
Published
2023-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232371000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232371000Actinia® hip stemsImplantcast GmbH2023-10-19LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048844196554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844196554040488441965544048844196554

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
324369826
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048844007966n/a028200022026-05-06
04048844017293NA258628002026-05-06
04048844017316NA258628102026-05-06
04048844111250NA258640002026-05-06
04048844111267NA258640052026-05-06
04048844111274NA258640102026-05-06
04048844111281NA258640152026-05-06
04048844150228n/a028200402026-05-06
04048844708344EPORE® XO022080422026-05-06
04048844708375EPORE® XO022080442026-05-06
04048844708405EPORE® XO022080462026-05-06
04048844708429EPORE® XO022080482026-05-06
04048844708450EPORE® XO022080522026-05-06
04048844708467EPORE® XO022080542026-05-06
04048844711566EPORE® XO022080562026-05-06
04048844711573EPORE® XO022080582026-05-06
04048844711580EPORE® XO022080602026-05-06
04048844711603EPORE® XO022080642026-05-06
04048844711610EPORE® XO022080662026-05-06
04048844711627EPORE® XO022080682026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07611996074901SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075007SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996075038SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095586SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095586SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095593SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095593SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095609SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095616SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095616SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095623SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095630SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19