FDA Registration
Active
🇺🇸 United States
Tyber Medical
Reg #: 3017980495
·
FEI: 3017980495
·
Expires 2026
Products
25
Proprietary Names
47
Establishment Types
4
Classifications
25
Registration Details
- Registration Name
- Tyber Medical
- Registration Number
- 3017980495
- FEI Number
- 3017980495
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 89 South Commerce Way, Suite 990
- City
- Bethlehem
- State
- PA
- ZIP
- 18017
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221947
Owner / Operator
- Firm Name
- Tyber Medical LLC
- Operator Number
- 10046574
- Address
- 89 South Commerce Way, Suite 990
- City
- Bethlehem
- State
- PA
- Postal Code
- 18017
- Country
- US
- Correspondent
- Lisa Boyle
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2022-11-09 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2022-11-09 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-11-09 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2026-06-08 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2025-02-21 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2023-03-16 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2014-04-09 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2014-04-09 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2024-10-09 |
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2017-12-22 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2022-08-04 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2025-04-08 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2025-02-21 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-08-05 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2025-02-21 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-06-08 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2020-12-03 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2025-02-21 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2025-02-21 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2023-12-15 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2025-02-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-05-19 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2014-04-09 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2025-02-21 |
| Template | HWT | Class 1 | Orthopedic | No | 2024-10-09 |
Proprietary Names
Staple System
Anatomical Plating System
Retractor
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
Rasp
Bit, drill
Penfield (dissector)
Impactable Tracker
Screwdriver
Slap Hammer
Curette
Wire System
Navigated Instruments
Rongeurs
BioTy Nanotopography Trauma Screw
General Instruments
Tyber Medical Sterilization Tray
Box Cutter
Paddle Shaver
Cobb
Guide Block
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility