BIOACCESS, INC.

FDA Device Registration & Listing · BALTIMORE, MD, US · Registration 1124621

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
1124621
FEI Number
1000513050
Entity Name
BIOACCESS, INC.
City/State/Country
BALTIMORE, MD, US
Establishment Address
4000 HUDSON ST., BALTIMORE, MD 21224, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
BIOACCESS, INC. (Owner Number: 9031105)
Owner / Operator Contact Address
4000 HUDSON ST., --, Baltimore, MD 21224, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K863734
PMA Number
N/A

All Registered Proprietary Names

NGD-1005A, Next Gen Driver with chuck NGD-1000, Next Gen Driver SMALL BONE TOOL (SBT 1000 SBT 1004) SBT 1003 SBT 1001 BioAccess Traction Pin Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2004-04-22
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2016-07-27

Official Correspondent

ROBERT CHAPOLINI

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOACCESS, INC.
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
K895079 Buckman Co., Inc. ACE BEADED K-WIRES ACE OLIVE WIRES 1989-09-13
K922193 Osteo AG OSTEO KIRSCHNER WIRE 1992-07-23
K850026 Kirkstil Corp., Inc. ORTHOPEDIC IMPLANT NAILS & PINS 1985-05-20
K963367 Rms Div. RMS K-WIRE 1996-10-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-05 Biomet, Inc. 2
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1124621. Last updated year: 2026. Please use registration number 1124621 when referencing this establishment in official correspondence.
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