FDA.reportPublic FDA data

ic-head Biolox®delta taper 12/14

Primary DI
04048844017330
Brand
ic-head Biolox®delta taper 12/14
Company
implantcast GmbH
Model
25863205
Published
2018-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048844017330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844017330040488440173304048844017330

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic femoral head prosthesisA sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
324369826
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048844693367implaFit®800900012026-03-26
04048844693411implaFit®800900062026-03-26
04048844693442implaFit®800900092026-03-26
04048844693510implaFit®800910032026-03-26
04048844693565implaFit®800910082026-03-26
04048844693596implaFit®800910112026-03-26
04048844693350implaFit®800900002026-03-17
04048844693374implaFit®800900022026-03-17
04048844693381implaFit®800900032026-03-17
04048844693398implaFit®800900042026-03-17
04048844693404implaFit®800900052026-03-17
04048844693428implaFit®800900072026-03-17
04048844693435implaFit®800900082026-03-17
04048844693459implaFit®800900102026-03-17
04048844693466implaFit®800900112026-03-17
04048844693473implaFit®800900122026-03-17
04048844693497implaFit®800910012026-03-17
04048844693503implaFit®800910022026-03-17
04048844693527implaFit®800910042026-03-17
04048844693534implaFit®800910052026-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862660596N/AExactech, Inc.OQI2026-03-19
10885862660640N/AExactech, Inc.OQI2026-03-19
10885862660671NovationExactech, Inc.OQI2026-03-19
00889024686519G7® Revision Acetabular SystemZimmer, Inc.OQI2026-02-10
00889024686533G7® Revision Acetabular SystemZimmer, Inc.OQI2026-02-10
00889024686540G7® Revision Acetabular SystemZimmer, Inc.OQI2026-02-10
00889024686755G7® Revision Acetabular SystemZimmer, Inc.OQI2026-02-10
04719872143024U-Motion IIUNITED ORTHOPEDIC CORP.OQI2025-09-15
04719886893663U-Motion IIUNITED ORTHOPEDIC CORP.OQI2025-09-05
09348215134518Nebula Standard Offset Size 0SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134525Nebula Standard Offset Size 1SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134532Nebula Standard Offset Size 2SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134549Nebula Standard Offset Size 3SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134556Nebula Standard Offset Size 4SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134563Nebula Standard Offset Size 5SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134570Nebula Standard Offset Size 6SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134587Nebula Standard Offset Size 7SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134594Nebula Standard Offset Size 8SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134600Nebula Standard Offset Size 9SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134617Nebula Standard Offset Size 10SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137502Origin TT Standard Offset Size 6SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137519Origin TT Standard Offset Size 7SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137526Origin TT Standard Offset Size 8SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137533Origin TT Standard Offset Size 9SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137540Origin TT Standard Offset Size 10SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137557Origin TT Standard Offset Size 11SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137564Origin TT Standard Offset Size 12SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137571Origin TT High Offset Size 0SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137588Origin TT High Offset Size 1SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137595Origin TT High Offset Size 2SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20