FDA Registration
Active
🇺🇸 United States
Tyber Medical
Reg #: 3012966183
·
FEI: 3012966183
·
Expires 2026
Products
25
Proprietary Names
49
Establishment Types
3
Classifications
25
Registration Details
- Registration Name
- Tyber Medical
- Registration Number
- 3012966183
- FEI Number
- 3012966183
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 83 South Commerce Way, Suite 310
- City
- Bethlehem
- State
- PA
- ZIP
- 18017
- Country
- US
Regulatory Submissions
- 510(k) Number
- K252742
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 |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-11-19 |
| Template | HWT | Class 1 | Orthopedic | No | 2024-10-09 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-01-31 |
| 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 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2022-08-04 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2014-04-09 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2025-02-21 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2024-10-09 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2025-02-21 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-12-14 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2025-02-21 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2025-02-21 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2025-02-21 |
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2017-12-22 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2025-02-21 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2023-12-15 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2025-04-08 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2025-02-21 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2022-11-09 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2026-06-08 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-05-19 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-08-05 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2023-03-16 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2020-12-03 |
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
Penfield (dissector)
Staple System
Retractor
General Instruments
Anatomical Plating System
Toegrip
Bit, drill
Reamer
Screwdriver
BioTy Nanotopography Trauma Screw
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility