Tyber Medical

FDA Device Registration & Listing · Bethlehem, PA, US · Registration 3012966183

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
3012966183
FEI Number
3012966183
Entity Name
Tyber Medical
City/State/Country
Bethlehem, PA, US
Establishment Address
83 South Commerce Way, Suite 310, Bethlehem, PA 18017, US
Establishment Type(s)
Repack or Relabel Medical Device
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
N/A
PMA Number
N/A

All Registered Proprietary Names

Navigated Instruments Guide Block Tyber Medical PLIF Tyber Medical OLIF Tyber Medical ACIF Tyber Medical TLIF Tyber Medical ALIF Tyber Medical DLIF Countersink Tyber Medical Sterilization Tray Curette Depth Gauge Rongeurs Plating System Rasp Tyber Medical PT Interbody Spacer System Osteotome Slap Hammer TIGER TRACK Screw System 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 Wedge System Box Cutter Paddle Shaver Cobb Impactable Tracker Wire System Plating System Penfield (dissector) Staple System Retractor Wedge System Plating System General Instruments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-11-19
HWT Template Orthopedic Class 1 888.4800 2024-10-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-01-31
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
HWW Countersink Orthopedic Class 1 888.4540 2022-08-04
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2014-04-09
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-02-21
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2024-10-09
HTX Rongeur Orthopedic Class 1 888.4540 2025-02-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-12-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-14
HTR Rasp General, Plastic Surgery Class 1 878.4800 2025-02-21
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
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
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2025-02-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-08-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-09
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
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2025-02-21
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-06-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2023-12-15
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
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-02-21
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-11-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-01-31
GAD Retractor General, Plastic Surgery Class 1 878.4800 2026-06-08
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
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-01-16
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2014-05-19

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
3017980495 Tyber Medical Bethlehem, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
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
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012966183. Last updated year: 2026. Please use registration number 3012966183 when referencing this establishment in official correspondence.
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