Data / Medical devices / United States / Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics: FDA-registered device maker in Olyphant, PA, United States, 7 510(k) clearances

Name: Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics is registered with the FDA (registration 3008812241) in Olyphant, PA, United States. It lists 8 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 15, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008812241
FEI number: 3006813973
Address: 1175 Mid Valley Dr, Olyphant, PA, United States, 18447
Owner or operator: MUSCULOSKELETAL TRANSPLANT FOUNDATION (9032400)
Roles: Manufacturer, Repackager or relabeler
First device listed: December 16, 2013
Registered through: 2026
Brand names listed: ACT Kit, AFT, BD Single Use Syringe, DBX Dental, DBX Inject, DBX Mix, DBX Paste, DBX Putty and more

Devices it lists

Device	Product code	Class	Role	Source
Bone Grafting Material, Human Source	NUN	2	Manufacturer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Manufacturer	accessdata.fda.gov
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	MBP	2	Manufacturer	accessdata.fda.gov
Instruments Designed For Press-Fit Osteochondral Implants	QBO	2	Repackager or relabeler	accessdata.fda.gov
Lipoaspirate Washing System For Aesthetic Body Contouring	QKL	2	Manufacturer	accessdata.fda.gov
Methyl Methacrylate For Cranioplasty	GXP	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	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
March 15, 2019	K181633	MTF Pre-Sutured Tendon	GAT	Substantially Equivalent	Musculoskeletal Transplant Foundation	accessdata.fda.gov
May 13, 2011	K110771	BD SINGLE USE, HYPODERMIC SYRINGE	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
June 9, 2010	K100754	GRAFT DELIVERY SYSTEM MODEL SA-6115	FMF	Substantially Equivalent	Micromedics, Inc.	accessdata.fda.gov
September 28, 2009	K091218	DBX DEMINERALIZED BONE MATRIX PUTTY	MQV	Substantially Equivalent	Musculoskeletal Transplant Foundation	accessdata.fda.gov
July 28, 2005	K042125	AFT	MQV	Substantially Equivalent	Musculoskeletal Transplant Foundation	accessdata.fda.gov
April 29, 2005	K040501	DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX	NUN	Substantially Equivalent	Musculoskeletal Transplant Foundation	accessdata.fda.gov
March 17, 2005	K040262	DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX	MQV	Substantially Equivalent	Musculoskeletal Transplant Foundation	accessdata.fda.gov

Compare with other makers

Updated March 15, 2019. 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.