FDA.reportPublic FDA data

SYNOVO HIP COMPONENTS

Primary DI
00814193025982
Brand
SYNOVO HIP COMPONENTS
Company
Synovo Production
Model
01-17-2840
Catalog number
01-17-2840
Device description
HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 40 MM O.D.
Published
2024-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWLProsthesis, Hip, Hemi-, Femoral, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884889000MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.Protek, Inc.1989-02-27KWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814193025982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814193025982008141930259828141930259820814193025982

GMDN Terms#

Term, Definition table
TermDefinition
Bipolar humeral head outer componentAn implantable, hemisphere-shaped component of a bipolar partial shoulder prosthesis designed to interface with the glenoid fossa on its outer surface where it freely rotates, and interface with a humeral head prosthesis on its inner surface where it allows free rotation of the head. It is typically composed of an outer metal shell and an inner polyethylene (PE) liner.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter28Millimeter
Outer Diameter40Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
061486164
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814193025975SYNOVO HIP COMPONENTS01-17-283901-17-28392024-03-14
00814193025999SYNOVO HIP COMPONENTS01-17-284201-17-28422024-03-14
00814193026002SYNOVO HIP COMPONENTS01-17-284101-17-28412024-03-14
00814193026019SYNOVO HIP COMPONENTS01-17-284301-17-28432024-03-14
00814193026026SYNOVO HIP COMPONENTS01-17-284401-17-28442024-03-14
00814193026033SYNOVO HIP COMPONENTS01-17-284501-17-28452024-03-14
00814193026040SYNOVO HIP COMPONENTS01-17-284601-17-28462024-03-14
00814193026057SYNOVO HIP COMPONENTS01-17-284701-17-28472024-03-14
00814193026064SYNOVO HIP COMPONENTS01-17-284801-17-28482024-03-14
00814193026071SYNOVO HIP COMPONENTS01-17-284901-17-28492024-03-14
00814193026088SYNOVO HIP COMPONENTS01-17-285001-17-28502024-03-14
00814193026095SYNOVO HIP COMPONENTS01-17-285201-17-28522024-03-14
00814193026101SYNOVO HIP COMPONENTS01-17-285101-17-28512024-03-14
00814193026118SYNOVO HIP COMPONENTS01-17-285301-17-28532024-03-14
00814193026125SYNOVO HIP COMPONENTS01-17-285401-17-28542024-03-14
00814193026132SYNOVO HIP COMPONENTS01-17-285501-17-28552024-03-14
00814193026149SYNOVO HIP COMPONENTS01-17-285601-17-28562024-03-14
00814193026156SYNOVO HIP COMPONENTS01-17-285701-17-28572024-03-14
00814193026163SYNOVO HIP COMPONENTS01-17-285801-17-28582024-03-14
00814193025760SYNOVO HIP COMPONENTS01-01-054601-01-05462024-03-04

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