FDA.reportPublic FDA data

Anatomical Shoulder™

Primary DI
00889024287488
Brand
Anatomical Shoulder™
Company
Zimmer GmbH
Model
01.04239.151
Catalog number
01.04239.151
Published
2021-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWAIMPACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024287488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024287488008890242874888890242874880889024287488

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
488133448
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
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
10885862648150EquinoxeExactech, Inc.HWA2026-03-19
09421038412220Enztec XR Trinket M8X1.0-01ENZTEC LIMITEDHWA2026-03-13
00840277133403Innomed, Inc.INNOMED, INC.HWA2026-03-11
00810123209934Adler Instrument CompanyAdler, Inc.HWA2026-03-03
05056405508578Charnley Femoral Prosthesis PusherPLATTS & NISBETT LIMITEDHWA2026-02-11
00822409133178N/AOrtho Development CorporationHWA2026-02-05
00822409133185N/AOrtho Development CorporationHWA2026-02-05
00822409133192N/AOrtho Development CorporationHWA2026-02-05
00822409133215N/AOrtho Development CorporationHWA2026-02-05
10603295554974EMPHASYSDEPUY ORTHOPAEDICS, INC.HWA2026-02-04
04026575048168General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2026-02-02
04026575080182General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2026-02-02
08800017299358BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887734BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887826BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887833BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373888021BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373888045BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
09421028112536Enztec Classic OCI - Trinket 5/16-24 UNF-02ENZTEC LIMITEDHWA2026-01-12
09421028113540Enztec Classic OCI - Trinket 3/8-16 UNC-01ENZTEC LIMITEDHWA2026-01-12
09421028113557Enztec Classic OCI - Trinket 5/16-24 UNF-01ENZTEC LIMITEDHWA2026-01-12
09421028113571Enztec Classic OCI - Trinket 3/8-24 UNF-01ENZTEC LIMITEDHWA2026-01-12
04026575448500General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
04026575448517General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
04026575448524General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
09421038410516 ATTUNE FEMORAL IMPACTORENZTEC LIMITEDHWA2025-10-21
09421038410523ATTUNE FEMORAL IMPACTOR HEADENZTEC LIMITEDHWA2025-10-21
00190446924470DJO SURGICALEncore Medical, L.P.HWA2025-10-10
09309000394289MAC SurgicalMAC SURGICAL PTY LTDHWA2025-09-30
09309000394296MAC SurgicalMAC SURGICAL PTY LTDHWA2025-09-30