FDA.report

Veritas rTSA

Primary DI
00840097515625
Brand
Veritas rTSA
Company
Restor3d, Inc.
Model
1501-4001
Device description
CoCr Glenosphere w/ Ti Security Screw, 40mm, +0mm
Published
2025-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
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
00840097515625PrimaryGS10

GMDN Terms

TermDefinition
Reverse shoulder prosthesis headA sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal or combined metal/polyethylene piece (glenosphere) intended to be attached to the reverse shoulder base plate, or directly to the glenoid fossa of the scapula, to articulate with the reverse shoulder cup.

Sterilization Methods

Method

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
false

Other Devices From This Company

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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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08033390002233SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390002240SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390002257SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390050029SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390050036SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390191135PRIMALIMACORPORATE SPAPHX2026-02-19
08033390201971PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202299PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202305PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202312PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202466PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202473PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202480PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202497PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202503PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202602PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202619PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202626PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202633PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202640PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202657PRIMALIMACORPORATE SPAPHX2026-02-19
08033390248433PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248556PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248563PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248587PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248594PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248600PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248617PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248624PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248631PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19