510(k) clearances

Veritas Shoulder System

restor3d, inc. · Orthopedic

K263421Substantially EquivalentSpecialPHX
Open FDA's page for this record
Third party flag
N
City
Durham
Advisory committee description
Orthopedic
Address 1
4001 Nc Hwy. 54
Address 2
Suite 3160
Statement or summary
Summary
Product code
PHX
Zip code
27709
Applicant
restor3d, inc.
Decision date
2026-10-22
Decision code
SESE
Country code
US
Device name
Veritas Shoulder System
Advisory committee
OR
Contact
Knox Pittman
K number
K263421
State
NC
Date received
2026-09-25
Review advisory committee
OR
Postal code
27709
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Shoulder Prosthesis, Reverse Configuration
Medical specialty description
Orthopedic
Regulation number
888.3660
Device class
2
Registration number
3012818475, 3008868758, 1822565, 3009185591, 3002579136, 8043792, 3014302784, 3010287737, 3014833750, 3021008900, 3033273230, 3006356043, 1835572, 1226544, 3019807891, 3002806603, 3006801265, 3010047402, 3007051929, 3013194153, 3005180920, 2244478, 1644408, 3006946276, 3013302242, 3009887475, 3015806723, 3010065126, 9613350, 3004976965, 3012552981, 3008395353, 3009871135, 3033509898, 3006984710, 3006017180, 3002807310, 3003998208, 3005596372, 3010400367 +153 more
FEI number
3012818475, 3008868758, 3009185591, 3002579136, 3014833750, 3014302784, 3010287737, 3021008900, 3033273230, 3002807036, 3006356043, 3019807891, 3002806603, 3006801265, 3010047402, 3007051929, 3013194153, 3005180920, 3002808269, 3006946276, 3013302242, 1000306303, 1000199976, 3003414678, 3009887475, 3003015552, 3015806723, 3010065126, 3004976965, 3012552981, 3008395353, 3009871135, 3002924544, 3000206435, 3006017180, 3033509898, 3006984710, 3003386935, 3002807310, 3003998208 +153 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.