FDA Registration
Active
🇺🇸 United States
Intrinsic Therapeutics, Inc.
Reg #: 3006232063
·
FEI: 3006232063
·
Expires 2026
Products
5
Proprietary Names
11
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- Intrinsic Therapeutics, Inc.
- Registration Number
- 3006232063
- FEI Number
- 3006232063
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 30 Commerce Way
- City
- Woburn
- State
- MA
- ZIP
- 01801
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201676
- PMA Number
- P160050
Owner / Operator
- Firm Name
- Intrinsic Therapeutics Inc.
- Operator Number
- 10023198
- Address
- 30 Commerce Way
- City
- Woburn
- State
- MA
- Postal Code
- 01801
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Defect Measurement Tool | QHG | Class 2 | Orthopedic | No | 2020-10-08 |
| Reherniation Reduction Device | QES | Class 3 | Unknown | No | 2019-02-25 |
| Template | HWT | Class 1 | Orthopedic | No | 2019-05-30 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2024-03-01 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-05-30 |
Proprietary Names
Intrsument Tray / Defect Mesurement Tool for Barricaid Annular Closure Device
Barricaid
Narrow Barricaid
Sizing Trials
Nerve Root Retractor, Suction
Extractor Weight
Impactor
Surgical Hammer
Removal Tool
Extractor
Retraction Wedge
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198