Identity
- Trade Name
- HEALIX TRANSTEND ORTHOCORD PERCANNULA FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- HEALIX TRANSTEND (Ti/2) IMPLANT SYSTEM (2) Titanium Anchors each with (1) Violet Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm), (1) PERCANNULASystem 4.0mm FDA UDI
- Model / Reference
- 222268 FDA UDI
- Description
- HEALIX TRANSTEND (Ti/2) IMPLANT SYSTEM (2) Titanium Anchors each with (1) Violet Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm), (1) PERCANNULASystem 4.0mm FDA UDI
Identifiers
- Catalog Number
- 222268 FDA UDI
- Primary DI / UDI-DI
- 10886705008148 FDA UDI
- 510(k) Number
- K102298 FDA UDI
- FDA Product Code
- MBI FDA UDIHWC FDA UDIMAI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Tendon/ligament bone anchor, non-bioabsorbable
Healix Transtend Orthocord Percannula by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102298 also covers:
- HEALIX BR ORTHOCORD — Medos International Sàrl
- HEALIX PEEK ORTHOCORD — Medos International Sàrl
- HEALIX TRANSTEND — Medos International Sàrl
- HEALIX TRANSTEND ORTHOCORD — Medos International Sàrl
- HEALIX TRANSTEND ORTHOCORD — Medos International Sàrl
- HEALIX TRANSTEND ORTHOCORD — Medos International Sàrl
- HEALIX TRANSTEND ORTHOCORD — Medos International Sàrl
- HEALIX TRANSTEND ORTHOCORD PERCANNULA — Medos International Sàrl
- HEALIX TRANSTEND ORTHOCORD PERCANNULA — Medos International Sàrl
- HEALIX TRANSTEND ORTHOCORD PERCANNULA — Medos International Sàrl
- HEALIX TRANSTEND ORTHOCORD PERCANNULA — Medos International Sàrl
- HEALIX TRANSTEND ORTHOCORD PERCANNULA — Medos International Sàrl
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
- Medos International Sàrl
Sources (1)
- FDA UDI 44b932f3-6441-4015-a4bc-729230bdf8b7 37 fields · synced May 30, 2026