Tyber Medical

FDA Device Registration & Listing · Bethlehem, PA, US · Registration 3017980495

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
3017980495
FEI Number
3017980495
Entity Name
Tyber Medical
City/State/Country
Bethlehem, PA, US
Establishment Address
89 South Commerce Way, Suite 990, Bethlehem, PA 18017, US
Establishment Type(s)
Manufacture Medical Device,Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Tyber Medical LLC (Owner Number: 10046574)
Owner / Operator Contact Address
89 South Commerce Way, Suite 990, Bethlehem, PA 18017, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231339
PMA Number
N/A

All Registered Proprietary Names

Staple System Anatomical Plating System Retractor Anatomical Plating System Osteotome Reamer Tyber Medical Ø2.5 HCS Tyber Medical Ø3.5 HCS Tyber Medical Ø9 HCS Tyber Medical Ø6 HCS Tyber Medical Ø8 HCS Tyber Medical Ø2 HCS Tyber Medical Ø4.5 HCS Tyber Medical Ø3 HCS Tyber Medical Ø1.5 HCS Tyber Medical Ø4 HCS Tyber Medical Ø5 HCS Tyber Medical Ø6.5 HCS Tyber Medical Ø5.5 HCS Tyber Medical Ø7 HCS Tyber Medical PLIF Tyber Medical OLIF Tyber Medical ACIF Tyber Medical TLIF Tyber Medical ALIF Tyber Medical DLIF Plating System Depth Gauge Tyber Medical PT Interbody Spacer System Wedge System Countersink Wedge System Plating System Rasp Bit, drill Penfield (dissector) Impactable Tracker Screwdriver Slap Hammer Curette Wire System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-11-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-11-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-09
GAD Retractor General, Plastic Surgery Class 1 878.4800 2026-06-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-01-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-03-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-16
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2025-02-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-08-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-08-13
HTO Reamer Orthopedic Class 1 888.4540 2023-03-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-04-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-04-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-12-15
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2024-10-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-01-29
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-01-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-22
PLF Bone Wedge Orthopedic Class 2 888.3030 2017-12-22
HWW Countersink Orthopedic Class 1 888.4540 2022-08-04
PLF Bone Wedge Orthopedic Class 2 888.3030 2017-12-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-01-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-05-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-04-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-04-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-04-08
HTR Rasp General, Plastic Surgery Class 1 878.4800 2025-02-21
HTW Bit, Drill Orthopedic Class 1 888.4540 2022-08-05
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-02-21
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-06-08
LRZ Screwdriver, Surgical General, Plastic Surgery Class 1 878.4800 2020-12-03
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2025-02-21
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-02-21
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2023-12-15

Official Correspondent

Lisa Boyle

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012966183 Tyber Medical Bethlehem, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K153770 In2bones Sas OS2(R)-VP Varisation Staple 2016-03-21
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16

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
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

Similar Registrations

Registration Number Establishment Name Location
3039081660 BLAZE BIOTECH, LLC San Antonio, TX, US
3027848094 MENTOR SUPPLY CHAIN (USA) INC Warsaw, IN, US
3014527966 F & A FOUNDATION Tulsa, OK, US
1833920 INSTRU-MED TECHNOLOGIES Warsaw, IN, US
1058584 Sterigenics US LLC Charlotte, NC, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017980495. Last updated year: 2026. Please use registration number 3017980495 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.