Data / Medical devices / Hydrogel Spacer
Hydrogel Spacer (OVB): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Hydrogel Spacer (product code OVB, Class 2, 21 CFR 892.5725). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on September 11, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OVB
- Device class
- 2
- Regulation
- 892.5725
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Ireland | 1 |
| Israel | 1 |
| Sweden | 1 |
Makers of Hydrogel Spacer
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 4 | September 11, 2026 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Limited | CORK Munster, Ireland | Manufacturer | 4 | September 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 3 | February 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Bioprotect Ltd. | Netanya Central, Israel | Manufacturer | 1 | August 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Palette Life Sciences | Santa Barbara, CA, United States | Manufacturer | 1 | May 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Q-Med AB | Uppsala, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.K. Manufacturing | Danbury, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 11, 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.