Identity
- Trade Name
- PONTiS Flexor Tendon Repair System FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader Kit Each Kit contains: 1x Dilating catheter for tendon transfer and pulley dilation 1x Funnel for tendon transfer 1x SS threader for threading sutures through the catheter & funnel Supplied pouched, sterilized with EO. FDA UDI
- Model / Reference
- 400-3014 FDA UDI
- Description
- PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader Kit Each Kit contains: 1x Dilating catheter for tendon transfer and pulley dilation 1x Funnel for tendon transfer 1x SS threader for threading sutures through the catheter & funnel Supplied pouched, sterilized with EO. FDA UDI
Identifiers
- Catalog Number
- 400-3014 FDA UDI
- Primary DI / UDI-DI
- 00859210006018 FDA UDI
- 510(k) Number
- K081060 FDA UDI
- FDA Product Code
- GAQ FDA UDI
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4495 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Suturing unit, single-use
PONTiS Flexor Tendon Repair System by Pontis Orthopaedics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081060 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pontis Orthopaedics, LLC
Sources (1)
- FDA UDI 3a867bfe-fdc7-49ad-a8e6-79bb70e28476 36 fields · synced May 31, 2026