Velora Acetabular System

GUDID 00840097533001

Velora Liner, GRP F (54), 36mm, STD

Restor3d, Inc.

Non-constrained polyethylene acetabular liner
Primary Device ID00840097533001
NIH Device Record Keyd7128b63-1016-45f2-84b4-52ae5f863782
Commercial Distribution StatusIn Commercial Distribution
Brand NameVelora Acetabular System
Version Model Number3900-F036
Company DUNS080819836
Company NameRestor3d, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840097533001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-23
Device Publish Date2025-12-15

On-Brand Devices [Velora Acetabular System]

00840097533575Velora Liner, GRP K (72), 40mm, LAT
00840097533568Velora Liner, GRP K (72), 36mm, LAT
00840097533551Velora Liner, GRP J (64-70), 40mm, LAT
00840097533544Velora Liner, GRP J (64-70), 36mm, LAT
00840097533537Velora Liner, GRP H (60-62), 40mm, LAT
00840097533520Velora Liner, GRP H (60-62), 36mm, LAT
00840097533513Velora Liner, GRP G (56-58), 40mm, LAT
00840097533506Velora Liner, GRP G (56-58), 36mm, LAT
00840097533490Velora Liner, GRP F (54), 40mm, LAT
00840097533483Velora Liner, GRP F (54), 36mm, LAT
00840097533476Velora Liner, GRP E (52), 40mm, LAT
00840097533469Velora Liner, GRP E (52), 36mm, LAT
00840097533452Velora Liner, GRP D (50), 36mm, LAT
00840097533445Velora Liner, GRP C (48), 36mm, LAT
00840097533438Velora Liner, GRP B (44-46), 32mm, LAT
00840097533421Velora Liner, GRP A (40-42), 28mm, LAT
00840097533414Velora Liner, GRP K (72), 40mm, FCL
00840097533407Velora Liner, GRP K (72), 36mm, FCL
00840097533391Velora Liner, GRP J (64-70), 40mm, FCL
00840097533384Velora Liner, GRP J (64-70), 36mm, FCL
00840097533377Velora Liner, GRP H (60-62), 40mm, FCL
00840097533360Velora Liner, GRP H (60-62), 36mm, FCL
00840097533353Velora Liner, GRP G (56-58), 40mm, FCL
00840097533346Velora Liner, GRP G (56-58), 36mm, FCL
00840097533339Velora Liner, GRP F (54), 40mm, FCL
00840097533322Velora Liner, GRP F (54), 36mm, FCL
00840097533315Velora Liner, GRP E (52), 40mm, FCL
00840097533308Velora Liner, GRP E (52), 36mm, FCL
00840097533292Velora Liner, GRP D (50), 36mm, FCL
00840097533285Velora Liner, GRP C (48), 36mm, FCL
00840097533278Velora Liner, GRP B (44-46), 32mm, FCL
00840097533261Velora Liner, GRP A (40-42), 28mm, FCL
00840097533254Velora Liner, GRP K (72), 40mm, LIP
00840097533247Velora Liner, GRP K (72), 36mm, LIP
00840097533230Velora Liner, GRP J (64-70), 40mm, LIP
00840097533223Velora Liner, GRP J (64-70), 36mm, LIP
00840097533216Velora Liner, GRP H (60-62), 40mm, LIP
00840097533209Velora Liner, GRP H (60-62), 36mm, LIP
00840097533193Velora Liner, GRP G (56-58), 40mm, LIP
00840097533186Velora Liner, GRP G (56-58), 36mm, LIP
00840097533179Velora Liner, GRP F (54), 40mm, LIP
00840097533162Velora Liner, GRP F (54), 36mm, LIP
00840097533155Velora Liner, GRP E (52), 40mm, LIP
00840097533148Velora Liner, GRP E (52), 36mm, LIP
00840097533131Velora Liner, GRP D (50), 36mm, LIP
00840097533124Velora Liner, GRP C (48), 36mm, LIP
00840097533117Velora Liner, GRP B (44-46), 32mm, LIP
00840097533100Velora Liner, GRP A (40-42), 28mm, LIP
00840097533094Velora Liner, GRP K (72), 40mm, STD
00840097533087Velora Liner, GRP K (72), 36mm, STD
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