FDA.report

Veritas rTSA

Primary DI
00840097515892
Brand
Veritas rTSA
Company
Restor3d, Inc.
Model
1504-4818
Device description
00840097515892
Published
2025-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications

CodeDeviceSpecialtyClass
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions

SubmissionSupplement
K243643000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K243643000restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D2025-05-19PHX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840097515892PrimaryGS10

GMDN Terms

TermDefinition
Total reverse shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted with or without bone cement.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
080819836
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840097534947Total Knee Instrumentation 5201-10012025-10-10
00840097534954Total Knee Instrumentation 5201-10022025-10-10
00840097534961Total Knee Instrumentation 5201-10032025-10-10
00840097513256Ossera™ AFX Instrumentation5740-00012025-12-18
00840097513263Ossera™ AFX Instrumentation5740-00022025-12-18
00840097513270Ossera™ AFX Instrumentation5740-00032025-12-18
00840097513287Ossera™ AFX Instrumentation5740-34262025-12-18
00840097515724Ossera™ AFX Instrumentation5740-34362025-12-18
00840097515731Ossera™ AFX Instrumentation5740-34402025-12-18
00840097519333Ossera™ AFX1740-34262025-12-18
00840097519340Ossera™ AFX1740-34362025-12-18
00840097519357Ossera™ AFX1740-36322025-12-18
00840097519364Ossera™ AFX1740-36422025-12-18
00840097519371Ossera™ AFX1740-40362025-12-18
00840097519388Ossera™ AFX1740-40462025-12-18
00840097532370Ossera™ AFX Instrumentation5740-36322025-12-18
00840097532387Ossera™ AFX Instrumentation5740-36362025-12-18
00840097533599Ossera™ AFX Instrumentation5741-24012025-12-18
00840097533612Ossera™ AFX Instrumentation5741-34012025-12-18
00840097533629Ossera™ AFX Instrumentation5741-36012025-12-18

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