BLAZE BIOTECH, LLC

FDA Device Registration & Listing · San Antonio, TX, US · Registration 3039081660

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3039081660
FEI Number
3039081660
Entity Name
BLAZE BIOTECH, LLC
City/State/Country
San Antonio, TX, US
Establishment Address
4600 Lockhill Selma Rd Ste 107, San Antonio, TX 78249, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Blaze Biotech, LLC (Owner Number: 10093736)
Owner / Operator Contact Address
4600 Lockhill Selma Rd. Ste. 107, San Antonio, TX 78249, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

A’TOMIC™ Nitinol Fixation System A'TOMIC PULSE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2025-06-30
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2025-08-19

Official Correspondent

Monica Lesch

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Blaze Biotech, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K153770 In2bones Sas OS2(R)-VP Varisation Staple 2016-03-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2023 Synthes (USA) Products LLC 2
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039081660. Last updated year: 2026. Please use registration number 3039081660 when referencing this establishment in official correspondence.
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