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Data / Medical devices / Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) (MBP): 34 FDA-registered makers in 2 countries

34 establishments in 2 countries are registered with the FDA to make Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) (product code MBP, Class 2, 21 CFR 888.3045). 13 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 31 510(k) clearances under this code, the latest on November 21, 2024, and lists 13 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
MBP
Device class
2
Regulation
888.3045
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States33
South Korea1

Makers of Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Osteotech, Inc.Eatontown, NJ, United StatesManufacturer4March 6, 2013020api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer3June 7, 2007000api.fda.gov
Isotis Orthobiologics, IncIrvine, CA, United StatesComplaint file establishment, Manufacturer3March 17, 2011000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer3March 6, 2013040api.fda.gov
Lifenet HealthVirginia Beach, VA, United StatesManufacturer2November 21, 2024000api.fda.gov
LifeNet HealthVirginia Bch, VA, United StatesManufacturer2November 21, 2024000api.fda.gov
LifeNet HealthPlainfield, IN, United StatesManufacturer2November 21, 2024000api.fda.gov
Hans Biomed Corp.Daejeon, South KoreaManufacturer1November 15, 2012000api.fda.gov
LifeNet Health NorthwestRenton, WA, United StatesManufacturer1November 28, 2005000api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)Alachua, FL, United StatesManufacturer1September 6, 2006000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer1January 26, 2006010api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer1January 26, 2006000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesManufacturer, Repackager or relabeler1May 31, 2013030api.fda.gov
AllosourceCentennial, CO, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Amend Surgical, Inc.Alachua, FL, United StatesManufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Bone Solutions, Inc.Colleyville, TX, United StatesManufacturer0000api.fda.gov
Berkeley Advanced BiomaterialsBerkeley, CA, United StatesManufacturer0000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Testing - CT, LLCWillington, CT, United StatesContract manufacturer0000api.fda.gov
Musculoskeletal Transplant Foundation d/b/a/ MTF BiologicsOlyphant, PA, United StatesManufacturer0000api.fda.gov
Musculoskeletal Transplant Foundation d/b/a/ MTF BiologicsEdison, NJ, United StatesManufacturer0010api.fda.gov
Musculoskeletal Transplant Foundation d/b/a/ MTF BiologicsJessup, PA, United StatesManufacturer0000api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Secada Medical, LLC D.B.A Ventris MedicalNewport Beach, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sterigenics Radiation Technologies, LLCSan Diego, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov

Updated November 21, 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.