Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014554088

FEI Number

3014554088

Entity Name

OSSIO LTD.

City/State/Country

Caesarea Central, IL

Establishment Address

8 HaTochen St., Caesarea Central 3079861, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ossio Ltd. (Owner Number: 10059524)

Owner / Operator Contact Address

8 HaTochen St., Caesarea, IL-NOTA 3079861, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213415

PMA Number

N/A

All Registered Proprietary Names

OSSIO Compression Screw Instruments OSSIO Orthopedic Cannulated Nail Instrument Pack OSSIO Single-Use AO Handle OSSIO Tap OSSIO Tap Pack OSSIOfiber Trimmable Fixation Nail, Cannulated OSSIOfiber Compression Screw OSSIOfiber Trimmable Fixation Nail OSSIOfiber® Suture Anchor 2.5 mm OSSIOfiber® Suture Anchor 3.5 mm OSSIOfiber® Suture Anchor 2.5-3.5 mm OSSIOfiber Compression Staple OSSIOfiber® Compression Staple OSSIO Punch OSSIO Punch Pack OSSIOfiber Hammertoe Fixation Implant OSSIOfiber Bone Pin Product Family OSSIOfiber® Trimmable Fixation Nail OSSIOfiber® Hammertoe Fixation System OSSIOfiber® Hammertoe Fixation Implant Hammertoe Instrumentation Kit, Size Medium OSSIO Drill Bit & Drill Guide OSSIO Drill Bit OSSIO Drill Bit & Drill Guide Pack OSSIO Drill Pack 1.8mm Instrument Pack For 2.5mm Suture Anchor Compression Screw Instruments OSSIOfiber Suture Anchor OSSIOfiber® Suture Anchor OSSIOfiber Compression Staple OSSIO Orthopedic Staple Instrument Pack OSSIOfiber® Trimmable Fixation Nail System OSSIOfiber® Trimmable Fixation Nail System, Cannulated OSSIOfiber® Suture Anchor System OSSIOfiber® Compression Staple System OSSIOfiber® Threaded Trimmable Fixation Nail System OSSIOfiber® Compression Screw OSSIO Drill Guide OSSIOfiber Trimmable Fixation Nail, 4x100mm, Cannulated OSSIOfiber Suture Anchor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-02-17
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2023-05-14
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2024-01-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-01-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-05-08
MNU	Staple, Absorbable	Orthopedic	Class 2	888.3030	2022-11-21
MNU	Staple, Absorbable	Orthopedic	Class 2	888.3030	2024-03-14
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-05-23
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2019-01-30
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2020-03-11
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2019-01-31
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2026-04-13
MNU	Staple, Absorbable	Orthopedic	Class 2	888.3030	2024-09-30
HXJ	Staple Driver	Orthopedic	Class 1	888.4540	2022-11-21
OJH	Orthopedic Tray	General, Plastic Surgery	Class 1	878.4800	2020-06-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-09-07
LXI	Guide, Drill, Ligament	General, Plastic Surgery	Class 1	878.4820	2022-05-23
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2024-01-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-05-23

Official Correspondent

Taly Lindner

US Agent Details

Bryan Jones Business: OSSIO INC. Email: bjones@ossio.io Phone: (978) 2898312

Related Public Records

Same Entity

Ossio Ltd.

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
K213415	OSSIO , Ltd.	OSSIOfiber Suture Anchor	2022-03-28
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-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014554088. Last updated year: 2026. Please use registration number 3014554088 when referencing this establishment in official correspondence.