FDA.reportPublic FDA data

Alloclassic® Zweymüller® SLO

Primary DI
H8440100121000
Brand
Alloclassic® Zweymüller® SLO
Company
Zimmer GmbH
Model
01.00121.000
Device description
ALLOCLASSIC OFFSET Stem 0
Published
2016-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033664000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033664000MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEMCenterpulse Orthopedics, Inc.2003-12-17LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024278028PrimaryGS10
H8440100121000SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024278028008890242780288890242780280889024278028

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined, and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
488133448
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
true
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
00887868453120Avenir®01.08000.01201.08000.0122021-02-25
00889024298521Natural Nail®47-2487-002-0047-2487-002-002015-10-21
00889024298538Natural Nail®47-2487-002-0547-2487-002-052015-10-21
00889024298545Natural Nail®47-2487-002-1047-2487-002-102015-10-21
00889024298552Natural Nail®47-2487-002-1547-2487-002-152015-10-21
00889024292512NCB®02.02261.0132024-05-03
00889024292550NCB®02.02261.1132024-05-03
00889024296558NCB®02.03156.0902024-05-03
00889024296565NCB®02.03156.0952024-05-03
00889024296572NCB®02.03156.1002024-05-03
00889024506503Affixus® Natural Nail®1100356641100356642019-03-21
00889024506510Affixus® Natural Nail®1100372371100372372019-03-21
00889024506527Affixus® Natural Nail®1100356651100356652019-03-21
00889024506534Affixus® Natural Nail®1100356661100356662019-03-21
00889024506558Affixus® Natural Nail®1100356681100356682019-03-21
00889024277038Dynesys® Top-Loading System01.03956.4502015-10-16
00889024283688Dynesys®01.03710.0062015-10-16
00889024283695Dynesys®01.03710.6452016-03-14
00889024283701Dynesys®01.03711.1002016-03-14
00889024283718Dynesys®01.03711.2002016-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E31442100200SignatureMaterialise NVKWY2026-09-24
E31442100300SignatureMaterialise NVKWY2026-09-24
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000033Triple Taper Stem Standard Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000040Triple Taper Stem High Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000057Triple Taper Stem Standard Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000064Triple Taper Stem High Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000071Triple Taper Stem Standard Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000088Triple Taper Stem High Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000095Triple Taper Stem Standard Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000101Triple Taper Stem High Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000118Triple Taper Stem Standard Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000125Triple Taper Stem High Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000132Triple Taper Stem Standard Offset Collared Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000149Triple Taper Stem High Offset Collared Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000156Triple Taper Stem Standard Offset Collarless Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22
09363272000163Triple Taper Stem High Offset Collarless Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWY2026-09-22