FDA Registration
Active
🇺🇸 United States
LinkBio Corp.
Reg #: 3006721341
·
FEI: 3006721341
·
Expires 2026
Products
12
Proprietary Names
17
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- LinkBio Corp.
- Registration Number
- 3006721341
- FEI Number
- 3006721341
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 69 King Street
- City
- Dover
- State
- NJ
- ZIP
- 07801
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241470
Owner / Operator
- Firm Name
- LinkBio Corp.
- Operator Number
- 10022893
- Address
- 69 King Street
- City
- Dover
- State
- NJ
- Postal Code
- 07801
- Country
- US
- Correspondent
- Terry Sheridan Powell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2021-02-04 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2025-04-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-06-08 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2022-06-08 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-06-08 |
| Template | HWT | Class 1 | Orthopedic | No | 2020-10-09 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2021-05-13 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-04-29 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-04-29 |
| Shoulder Arthroplasty Implantation System | QHE | Class 2 | Orthopedic | No | 2025-04-29 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2022-06-08 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2021-05-13 |
Proprietary Names
LinkBio Instrument Trays (Mega C)
LinkBio Instrument Trays (TrabecuLink Tibial Cones)
LinkBio Instrument Trays (TrabecuLink Cones Universal)
CORE Shoulder Instrument Tray
CORE Shoulder System Workstation Stand
LinkBio Instrument
LinkBio Instruments (Reamer template)
LinkBio Instrument (Impactor, Impactor Plate)
LinkBio Instrument (drill bit)
LinkBio Instruments (LSK Femoral Sizer)
LinkBio Instruments (Trials)
LinkBio Instruments (Tibial cone broach)
LinkBio Instruments (LSK Tensioner Blocks)
LinkBio Instruments (Broaches, Broach guide rods)
CORE Shoulder System
LinkBio Instruments (Reamers, Reamer Guides)
LinkBio Instruments (Starter Reamer)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility