Data / Medical devices / United States / Ebi Patient Care, Inc.
Ebi Patient Care, Inc.: FDA-registered device maker in Guaynabo, PR, United States, 4 PMA approvals
Ebi Patient Care, Inc. is registered with the FDA (registration 3003435252) in Guaynabo, PR, United States. It lists 2 device types. The FDA files 4 PMA approvals under its listings, the newest dated April 30, 1987. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003435252
- Address
- 484 Calle E, Guaynabo, PR, United States, 00969
- Owner or operator
- EBI, LLC - AHP EOS Buyer Inc. (2242816)
- Roles
- Manufacturer
- First device listed
- February 27, 2008
- Registered through
- 2026
- Brand names listed
- Biomet BHS Mini, Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System, Biomet Spinalpak Non-invasive Spine Fusion Stimulator System, EBI Bone Healing System, EBI Bone Healing System-Model 2100, EBI Osteogen Implantable Growth Sti, EBI SPF Implantable Spinal Fusion S and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Bone Growth, Non-Invasive | LOF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Invasive Bone Growth | LOE | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 30, 1987 | P850035 | SpF® Implantable Spinal Fusion Stimulator | LOE | 51 | September 20, 2024 | accessdata.fda.gov |
| February 18, 1986 | P850022 | Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy | LOF | 31 | February 29, 2024 | accessdata.fda.gov |
| January 25, 1980 | P790005 | OsteoGenTM Implantable Bone Growth Stimulators | LOE | 58 | November 23, 2022 | accessdata.fda.gov |
| November 6, 1979 | P790002 | Biomet(R) EBI BONE Healing System | LOF | 35 | October 26, 2023 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 20, 2017 | 77089 | Class I | Terminated | 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels. | Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product. | accessdata.fda.gov |
Compare with other makers
Updated September 20, 2024. 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.