Data / Medical devices / United States / Sanbor Medical

Sanbor Medical: FDA-registered device maker in Allentown, PA, United States, 2 510(k) clearances

Name: Sanbor Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sanbor Medical is registered with the FDA (registration 3007113169) in Allentown, PA, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 24, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007113169
Address: 7584 Morris Court Suite 218, Allentown, PA, United States, 18106
Owner or operator: Sanbor Medical (10028522)
Roles: Complaint file establishment, Contract manufacturer
First device listed: February 22, 2016
Registered through: 2026
Brand names listed: ReBuilder-2407; ReBuilder-300, Spiro PD Personal Spirometer

Devices it lists

Device	Product code	Class	Role	Source
Plate, Fixation, Bone	HRS	2	Complaint file establishment	accessdata.fda.gov
Prosthesis, Toe, Constrained, Polymer	KWH	2	Complaint file establishment	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Contract manufacturer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Contract 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
May 24, 2024	K233089	NeoSpan® Compression Implant System	HRS	Substantially Equivalent	In2bones USA, LLC	accessdata.fda.gov
September 8, 2016	K153609	RTS Flexible 1 MPJ Implant w/Grommets	KWH	Substantially Equivalent	In2bones USA, LLC	accessdata.fda.gov

Compare with other makers

Updated May 24, 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.