FDA.report

Equinoxe

Primary DI
10885862648044
Company
Exactech, Inc.
Model
313-01-41
Catalog number
313-01-41
Device description
Trial, Resurfacing Head
Published
2026-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
10885862648044PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
10885862648044PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
HWTTemplate1Orthopedic888.4800NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Humeral head prosthesis trial, reusableA copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueText
Outer Diameter41 Millimeter

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10885862609588Vantage351-21-23351-21-232026-03-19
10885862639622AcuMatch103-00-01103-00-012026-03-19
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10885862648051Equinoxe313-01-44313-01-442026-03-19
10885862648068Equinoxe313-01-47313-01-472026-03-19
10885862648075Equinoxe313-01-50313-01-502026-03-19
10885862648082Equinoxe313-01-53313-01-532026-03-19
10885862648099Equinoxe313-05-01313-05-012026-03-19
10885862648105Equinoxe313-05-02313-05-022026-03-19
10885862648129Equinoxe313-07-01313-07-012026-03-19
10885862648136Equinoxe313-07-02313-07-022026-03-19
10885862648143Equinoxe313-07-03313-07-032026-03-19
10885862648150Equinoxe313-07-05313-07-052026-03-19
10885862648167Equinoxe313-07-07313-07-072026-03-19
10885862648174Equinoxe313-07-10313-07-102026-03-19
10885862648259Equinoxe313-25-38313-25-382026-03-19
10885862648266Equinoxe313-25-41313-25-412026-03-19
10885862648273Equinoxe313-25-44313-25-442026-03-19
10885862648280Equinoxe313-25-47313-25-472026-03-19
10885862648297Equinoxe313-25-50313-25-502026-03-19

Other Devices Sharing Product Codes

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00888118145321PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00888118145338PURE PECTUSKLS-Martin L.P.HWT2026-03-23
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00889024706385OSS RS ROT Hinged Knee Provisional 16MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706392OSS RS ROT Hinged Knee Provisional 18MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706514REDUCED Z1 STD NECK TRL SZ 10-12Zimmer, Inc.HWT2026-03-19
00889024706521REDUCED Z1 STD NECK TRL SZ 0-9Zimmer, Inc.HWT2026-03-19
04046826472061MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472078MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472085MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
10885862609588VantageExactech, Inc.HWT2026-03-19
10885862648037EquinoxeExactech, Inc.HWT2026-03-19
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10885862648068EquinoxeExactech, Inc.HWT2026-03-19
10885862648075EquinoxeExactech, Inc.HWT2026-03-19
10885862648082EquinoxeExactech, Inc.HWT2026-03-19
10885862659712N/AExactech, Inc.HWT2026-03-19
10885862659729N/AExactech, Inc.HWT2026-03-19
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10885862659767N/AExactech, Inc.HWT2026-03-19
10885862659774N/AExactech, Inc.HWT2026-03-19
10885862659781N/AExactech, Inc.HWT2026-03-19
10885862659804N/AExactech, Inc.HWT2026-03-19
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10885862659835N/AExactech, Inc.HWT2026-03-19
10885862659842N/AExactech, Inc.HWT2026-03-19