Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat Lockdown Medical Ltd makes
Lockdown Medical Ltd manufactures synthetic polymer ligament grafts, bone anchors for orthopaedic fixation, and reusable surgical depth gauges. Their portfolio also includes single-use wire/ligature passers, ligament reconstruction instrument sets, and orthopaedic graft tensioners, alongside reusable instrument trays and non-torque-limiting surgical instrument handles.
The company’s devices are authorised as Class I and Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Lockdown Medical Ltd manufacture?
Lockdown Medical Ltd specialises in orthopaedic devices, primarily focusing on synthetic polymer ligament grafts, bone anchors for ligament fixation, and reusable surgical depth gauges. Their product range also includes single-use items like wire/ligature passers and ligament reconstruction instrument sets, as well as reusable instrument trays and non-torque-limiting surgical instrument handles. These devices are designed to support ligament and joint reconstruction procedures.
Where is Lockdown Medical Ltd based?
Lockdown Medical Ltd is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are authorised under FDA guidelines, ensuring compliance with US medical device regulations.
Which regulatory registries list Lockdown Medical Ltd’s devices?
Lockdown Medical Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorised for use in the US, ensuring transparency and traceability for healthcare providers and regulators.
How are Lockdown Medical Ltd’s devices classified under FDA regulations?
Lockdown Medical Ltd’s devices are authorised as either Class I or Class II medical devices under FDA regulations. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s purpose, intended use, and potential risks to patients.
What is the significance of Lockdown Medical Ltd’s device classifications?
The classification of Lockdown Medical Ltd’s devices as Class I or Class II determines the regulatory requirements they must meet. Class I devices typically require basic compliance with FDA general controls, such as proper labeling and manufacturing practices. Class II devices, however, must also adhere to specific performance standards or post-market surveillance to ensure safety and effectiveness, reflecting their slightly higher risk profile compared to Class I.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 211167885
Catalogue (48)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lsss | RM06008 | FDA UDI | Class I | Active |
| Ac Device | INSUR | FDA UDI | N/A | Active |
| Ac Device | LDSS34 | FDA UDI | Class II | Active |
| Ac Device | LD060 | FDA UDI | Class II | Active |
| Lsss | IN414 | FDA UDI | Class I | Active |
| Ac Device | INSUL | FDA UDI | N/A | Active |
| Lsss | RM04053 | FDA UDI | Class I | Active |
| Ac Device | LD170 | FDA UDI | Class II | Active |
| Ac Device | LDSS16 | FDA UDI | Class II | Active |
| Ac Device | LD090 | FDA UDI | Class II | Active |
| Ac Device | LD130 | FDA UDI | Class II | Active |
| Ac Device | LDSS26 | FDA UDI | Class II | Active |
| Ac Device | LDSS40 | FDA UDI | Class II | Active |
| Ac Device | LDSS28 | FDA UDI | Class II | Active |
| Lsss | RM06009 | FDA UDI | Class I | Active |
| Ac Device | LD110 | FDA UDI | Class II | Active |
| Ac Device | LD190 | FDA UDI | Class II | Active |
| Ac Device | LD140 | FDA UDI | Class II | Active |
| Lsss | RM06007 | FDA UDI | Class I | Active |
| Ac Device | LDCW09 | FDA UDI | Class II | Active |
| Ac Device | LDSS22 | FDA UDI | Class II | Active |
| Ac Device | LDSS36 | FDA UDI | Class II | Active |
| Ac Device | LD080 | FDA UDI | Class II | Active |
| Ac Device | LDLG | FDA UDI | Class I | Active |
| Ac Device | LDSS20 | FDA UDI | Class II | Active |
| Lsss | RM06005 | FDA UDI | Class I | Active |
| Ac Device | LDI627/S | FDA UDI | Class I | Active |
| Ac Device | LD070 | FDA UDI | Class II | Active |
| Ac Device | LDSS18 | FDA UDI | Class II | Active |
| Ac Device | LD050 | FDA UDI | Class II | Active |
| Lsss | RM06010 | FDA UDI | Class I | Active |
| Lsss | RM04953 | FDA UDI | Class I | Active |
| Lsss | RM04051 | FDA UDI | Class I | Active |
| Ac Device | LD120 | FDA UDI | Class II | Active |
| Ac Device | LD200 | FDA UDI | Class II | Active |
| Ac Device | LD180 | FDA UDI | Class II | Active |
| Ac Device | LD100 | FDA UDI | Class II | Active |
| Ac Device | LDIN628/S | FDA UDI | Class I | Active |
| Ac Device | LDSS32 | FDA UDI | Class II | Active |
| Lsss | RM06006 | FDA UDI | Class I | Active |
| Ac Device | LD160 | FDA UDI | Class II | Active |
| Lsss | IN413 | FDA UDI | Class I | Active |
| Ac Device | LDSS14 | FDA UDI | Class II | Active |
| Lsss | IN412 | FDA UDI | Class I | Active |
| Ac Device | LD150 | FDA UDI | Class II | Active |
| Ac Device | LDSS24 | FDA UDI | Class II | Active |
| Ac Device | LDSS30 | FDA UDI | Class II | Active |
| Ac Device | LDSS38 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.