Data / Medical devices / United States / LinkBio Corp.
LinkBio Corp.: FDA-registered device maker in Dover, NJ, United States, 1 510(k) clearance
LinkBio Corp. is registered with the FDA (registration 3006721341) in Dover, NJ, United States. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 20, 2025. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006721341
- Address
- 69 King Street, Dover, NJ, United States, 07801
- Owner or operator
- LinkBio Corp. (10022893)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 9, 2020
- Registered through
- 2027
- Brand names listed
- CORE Shoulder Instrument Tray, CORE Shoulder System, CORE Shoulder System Workstation Stand, LinkBio Instrument, LinkBio Instrument (Impactor, Impactor Plate), LinkBio Instrument (drill bit), LinkBio Instrument Trays (Mega C), LinkBio Instrument Trays (TrabecuLink Cones Universal) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Broach | HTQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Shoulder Arthroplasty Implantation System | QHE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Shoulder Prosthesis, Reverse Configuration | PHX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 20, 2025 | K241470 | CORE Shoulder System | QHE | Substantially Equivalent | LinkBio Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 12, 2026 | 98594 | Class II | Ongoing | LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136. | The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen. | accessdata.fda.gov |
| April 25, 2023 | 92294 | Class II | Ongoing | LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: /13 | Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left). | accessdata.fda.gov |
| March 21, 2023 | 92088 | Class II | Ongoing | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40 | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention | accessdata.fda.gov |
Compare with other makers
- All makers of Reamer
- All makers of Broach
- All makers of Impactor
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Template
- All makers of Tray, Surgical, Instrument
Updated April 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.