FDA.reportPublic FDA data

Spline®

Primary DI
00889024010994
Brand
Spline®
Company
ZimVie US Corp LLC
Model
0547
Published
2017-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024010994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024010994008890240109948890240109940889024010994

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-7019zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
119287313
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844868052814Terrats Competitive Connection AbutmentsMALDAGU2026-05-18
00844868052821Terrats Competitive Connection AbutmentsNALDAG352026-05-18
00844868052838Terrats Competitive Connection AbutmentsNBLDAG512026-05-18
00844868052845Terrats Competitive Connection AbutmentsTXLDAT32026-05-18
00844868052852Terrats Competitive Connection AbutmentsNRLDAG432026-05-18
00844868052890Terrats Competitive Connection AbutmentsMSLDAG372026-05-18
00844868052906Terrats Competitive Connection AbutmentsMSLDAT452026-05-18
00844868052913Terrats Competitive Connection AbutmentsNALDAG432026-05-18
00844868052937Terrats Competitive Connection AbutmentsNRLDAG502026-05-18
00844868052951Terrats Competitive Connection AbutmentsNBLDAG352026-05-18
00844868052968Terrats Competitive Connection AbutmentsSTLDAT652026-05-18
00844868053071Terrats Competitive Connection AbutmentsSXLDAT352026-05-18
00844868053088Terrats Competitive Connection AbutmentsNRLDAT602026-05-18
00844868053095Terrats Competitive Connection AbutmentsNBLDAG412026-05-18
00844868053101Terrats Competitive Connection AbutmentsNALDAT302026-05-18
00844868053118Terrats Competitive Connection AbutmentsNBLDAT352026-05-18
00844868053125Terrats Competitive Connection AbutmentsSTLDAT352026-05-18
00844868053132Terrats Competitive Connection AbutmentsEVLDAG482026-05-18
00844868053149Terrats Competitive Connection AbutmentsSXLDAG452026-05-18
00844868053156Terrats Competitive Connection AbutmentsNALDAT352026-05-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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