FDA Registration
Active
🇺🇸 United States
TCAT TKA Instrument Tray
Reg #: 3000719653
·
FEI: 3000719653
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- Think Surgical Inc.
- Registration Number
- 3000719653
- FEI Number
- 3000719653
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 47201 Lakeview Blvd
- City
- Fremont
- State
- CA
- ZIP
- 94538
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203468
Owner / Operator
- Firm Name
- Think Surgical Inc.
- Operator Number
- 10028805
- Address
- 47201 Lakeview Blvd
- City
- Fremont
- State
- CA
- Postal Code
- 94538
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2022-01-06 |
Proprietary Names
TCAT TKA Instrument Tray
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device