Identity
- Trade Name
- LUPINE ORTHOCORD FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- LUPINE Loop Dual Suture (DS) Anchor PLA Absorbable Anchor, with two size 2 (5 metric) ORTHOCORD braided composite sutures, Violet and Blue 36 Inches (91cm). Size 2 (5 metric) ORTHOCORD eyelet loop. FDA UDI
- Model / Reference
- 222981 FDA UDI
- Description
- LUPINE Loop Dual Suture (DS) Anchor PLA Absorbable Anchor, with two size 2 (5 metric) ORTHOCORD braided composite sutures, Violet and Blue 36 Inches (91cm). Size 2 (5 metric) ORTHOCORD eyelet loop. FDA UDI
Identifiers
- Catalog Number
- 222981 FDA UDI
- Primary DI / UDI-DI
- 10886705008599 FDA UDI
- FDA Product Code
- GAM FDA UDIMAI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4493 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- Not 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
Lupine Orthocord by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- DePuy Mitek, Inc.
Sources (1)
- FDA UDI 10f42d71-bf15-44c6-bab2-f7e764d72b84 37 fields · synced Jun 8, 2026