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Sign in to claim this brandLincotek Medical LLC
US
Last updated September 17, 2026
What Lincotek Medical LLC makes
Lincotek Medical LLC manufactures suturing devices including reusable suturing needle holders, single-use suturing needles, and reusable suturing units. Their specific products include the Champion Suture Passer Ratchet Humpback, Champion Suture Passer Ratchet Humpback Capture, Champion Suture Passer Needle, Champion Suture Passer Ratchet Straight Capture, Versipass Suture Passer Needle, Versipass Suture Passer, and Champion Suture Passer Ratchet Straight.
The company's devices are classified as Class I and are listed in the FDA Unique Device Identification (UDI) registry. Lincotek Medical LLC is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Lincotek Medical LLC manufacture?
Lincotek Medical LLC manufactures suturing devices including reusable suturing needle holders, single-use suturing needles, and reusable suturing units. Their specific products include the Champion Suture Passer series and Versipass Suture Passer.
Where is Lincotek Medical LLC based?
Lincotek Medical LLC is based in the United States. The company operates within the US to manufacture and distribute their medical devices.
Which regulatory registries list Lincotek Medical LLC's devices?
Lincotek Medical LLC's devices are listed in the FDA Unique Device Identification (UDI) registry. This registry provides information about medical devices distributed in the US market.
How are Lincotek Medical LLC's devices classified?
Lincotek Medical LLC's devices are classified as Class I medical devices. Class I devices are considered low-risk and subject to general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 3110 Stage Post Dr Ste 117, Bartlett, TN, 38133
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3011299238
- DUNS Number
- —
Catalogue (169)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Integrity-SI Fusion System | 1252-0006-035 | FDA UDI | Class II | Unknown |
| Integrity-SI Fusion System | 1252-1012-080 | FDA UDI | Class II | Unknown |
| Integrity-SI Fusion System | 1252-5200-000 | FDA UDI | Class II | Unknown |
| Integrity-SI Fusion System | 1252-1112-070 | FDA UDI | Class II | Unknown |
| Integrity-SI Fusion System | 1252-1110-071 | FDA UDI | Class II | Unknown |
| Integrity-SI Fusion System | 1252-1010-110 | FDA UDI | Class II | Unknown |
| Integrity-SI Fusion System | 1252-1110-096 | FDA UDI | Class II | Unknown |
| Integrity-SI Fusion System | 1252-4109 | FDA UDI | Class II | Unknown |
| Versipass Suture Passer | 4726 | FDA UDI | Class I | Active |
| Integrity-SI Fusion System | 1252-4102-002 | FDA UDI | Class II | Unknown |
| Integrity-SI Fusion System | 1252-1110-110 | FDA UDI | Class II | Unknown |
| Integrity-SI Fusion System | 1252-1012-070 | FDA UDI | Class II | Unknown |
| Integrity-SI Fusion System | 1252-4131 | FDA UDI | Class II | Unknown |
| Integrity-SI Fusion System | 1252-1112-111 | FDA UDI | Class II | Unknown |
| Integrity-SI Fusion System | 1252-1112-091 | FDA UDI | Class II | Unknown |
| Champion Suture Passer Ratchet Straight | 3910-900-086 | FDA UDI | Class I | Active |
| Integrity-SI Fusion System | 1252-1110-076 | FDA UDI | Class II | Unknown |
| SportLinc Syndesmosis Device | K252081 | FDA 510(k) | Class II | Active |
| SpineLinc Anterior Cervical Implant System | K250764 | FDA 510(k) | Class II | Active |
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