Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014833750

FEI Number

3014833750

Entity Name

restor3d, inc.

City/State/Country

Durham, NC, US

Establishment Address

4001 NC Hwy 54, Suite 2160, Durham, NC 27709, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

restor3d, inc. (Owner Number: 10058270)

Owner / Operator Contact Address

4001 NC Hwy 54, Suite 3160, Durham, NC 27709, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

H230003

All Registered Proprietary Names

restor3d Cervical Cage restor3d Cervical Interbody Fusion Device TIDAL Fusion Cage Ossera AFX System restor3d Disposable Instruments, Cervical Cage restor3d Lumbar Interbody Fusion Cage Veritas Reverse Total Shoulder System Velora Acetabular Cup iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System Kinos Axiom Total Ankle System restor3d Reverse Total Shoulder Kinos Axiom PSR System restor3d TiDAL Osteotomy Wedge restor3d TiDAL Wedge restor3d Osteotomy Wedge restor3d Total Talus Replacement

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2019-11-13
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2025-05-01
SAI	Ankle Fusion Cage	Orthopedic	Class 2	888.3020	2025-05-01
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-01-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-04-09
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2026-05-20
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2026-05-20
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2025-12-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-12-10
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-12-10
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-12-10
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2018-08-10
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2025-11-21
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2025-11-21
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2025-11-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-11-21
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2022-06-02
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-07-24
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-07-24
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2023-04-14
HWT	Template	Orthopedic	Class 1	888.4800	2022-12-20
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2019-11-13
QNN	Prosthesis, Total Talus Replacement, Metal	Unknown	Class f	N/A	2024-03-04
QYQ	Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal	Unknown	Class f	N/A	2024-03-04

Official Correspondent

Brianna Prindle

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

restor3d, inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014833750. Last updated year: 2026. Please use registration number 3014833750 when referencing this establishment in official correspondence.