FDA.reportPublic FDA data

OsseoFit™ Stemless Shoulder

Primary DI
00889024679092
Brand
OsseoFit™ Stemless Shoulder
Company
Zimmer, Inc.
Model
00-5381-004-25
Catalog number
00-5381-004-25
Published
2024-12-18
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
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024679092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024679092008890246790928890246790920889024679092

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707382Persona Tensor Sizer Arm – LongSSI008513SSI0085132026-05-29
00889024707399Persona Tensor Sizer Arm – StdSSI008567SSI0085672026-05-29
00889024707405Persona Tensor Sizer BodySSI008566SSI0085662026-05-29
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28
00889024081260XtraFix® Large External Fixation System00-5210-050-0200-5210-050-022016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048844758219EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758233EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758271EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758295EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758776n/aimplantcast GmbHHWT2026-06-02
04048844758820n/aimplantcast GmbHHWT2026-06-02
04048844758950n/aimplantcast GmbHHWT2026-06-02
04048844770747n/aimplantcast GmbHHWT2026-06-02
04048844770808n/aimplantcast GmbHHWT2026-06-02
04048844770891n/aimplantcast GmbHHWT2026-06-02
04048844770938n/aimplantcast GmbHHWT2026-06-02
04048844770952n/aimplantcast GmbHHWT2026-06-02
04048844770976n/aimplantcast GmbHHWT2026-06-02
00850011453544REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCHWT2026-06-01
10603295552680ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555001ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555018ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555025ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555032ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555049ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555056ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555544ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555582ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10885862660527AcuMatchExactech, Inc.HWT2026-05-28
10885862660541AcuMatchExactech, Inc.HWT2026-05-28
10885862660558AcuMatchExactech, Inc.HWT2026-05-28
10885862660565AcuMatchExactech, Inc.HWT2026-05-28
08806373887741BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887758BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887765BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12