Data / Medical devices / United Kingdom / Apatech Ltd.
Apatech Ltd.: FDA-registered device maker in ELSTREE Hertfordshire, United Kingdom, 20 510(k) clearances
Apatech Ltd. is registered with the FDA (registration 3004450973) in ELSTREE Hertfordshire, United Kingdom. It lists 4 device types. The FDA files 20 510(k) clearances under its listings, the newest dated August 2, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004450973
- Address
- 360 Centennial Avenue Centennial Park, ELSTREE Hertfordshire, United Kingdom, WD6 3TJ
- Owner or operator
- BAXTER HEALTHCARE CORPORATION (1417572)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 22, 2015
- Registered through
- 2026
- Brand names listed
- ALTAPORE, Actifuse, Actifuse ABX, Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS, Actifuse Flow, Actifuse Shape, Altapore MIS, Altapore Shape and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | KHJ | 2 | Manufacturer | accessdata.fda.gov |
| Wax, Bone | MTJ | U | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 2, 2024 | K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS | MQV | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| June 30, 2020 | K201464 | Altapore MIS | MQV | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| May 8, 2020 | K200640 | ALTAPORE SHAPE | MQV | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| January 9, 2020 | K192363 | Altapore | MQV | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| August 17, 2018 | K181306 | Actifuse Flow | MQV | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| October 8, 2010 | K102071 | OSTENE CT, AOC CT, OSTEOTENE, CERETENE | MTJ | Substantially Equivalent | Ceremed , Inc. | accessdata.fda.gov |
| July 30, 2009 | K090850 | ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE | LYC | Substantially Equivalent | Apatech , Ltd. | accessdata.fda.gov |
| June 22, 2009 | K091636 | OSTENE CT, AOC CT, OSTEOTENE, CERETENE | MTJ | Substantially Equivalent | Ceremed , Inc. | accessdata.fda.gov |
| November 25, 2008 | K082575 | ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES | MQV | Substantially Equivalent | Apatech , Ltd. | accessdata.fda.gov |
| November 6, 2008 | K081979 | ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | Apatech , Ltd. | accessdata.fda.gov |
| September 24, 2008 | K082491 | OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE | MTJ | Substantially Equivalent | Ceremed , Inc. | accessdata.fda.gov |
| September 11, 2008 | K082073 | ACTIFUSE FLOW BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | Apatech , Ltd. | accessdata.fda.gov |
| April 16, 2008 | K080736 | ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | Apatech , Ltd. | accessdata.fda.gov |
| May 31, 2007 | K071206 | ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | Apatech , Ltd. | accessdata.fda.gov |
| January 24, 2007 | K070093 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE | KHJ | Substantially Equivalent | Ceremed , Inc. | accessdata.fda.gov |
| December 11, 2006 | K062280 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE | KHJ | Substantially Equivalent | Ceremed , Inc. | accessdata.fda.gov |
| October 11, 2005 | K052528 | AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE | MTJ | Substantially Equivalent | Ceremed , Inc. | accessdata.fda.gov |
| March 24, 2005 | K050440 | AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 | MTJ | Substantially Equivalent | Ceremed , Inc. | accessdata.fda.gov |
| August 4, 2004 | K040082 | PORE-SI BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | Apatech , Ltd. | accessdata.fda.gov |
| July 27, 2004 | K041363 | AOC BONE WAX | MTJ | Substantially Equivalent | Ceremed , Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 18, 2015 | 74125 | Class II | Terminated | Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. | Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria. | accessdata.fda.gov |
Compare with other makers
- All makers of Wax, Bone
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Bone Grafting Material, Synthetic
- All makers of Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Updated August 2, 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.