Identity
- Trade Name
- HEALIX KNOTLESS BR FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- HEALIX Knotless BR Anchor TCP/PLGA Absorbable Anchor 4.75mm FDA UDI
- Model / Reference
- 222286 FDA UDI
- Description
- HEALIX Knotless BR Anchor TCP/PLGA Absorbable Anchor 4.75mm FDA UDI
Identifiers
- Catalog Number
- 222286 FDA UDI
- Primary DI / UDI-DI
- 10886705020386 FDA UDI
- 510(k) Number
- K112249 FDA UDI
- FDA Product Code
- HWC FDA UDIMAI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
MR Safe FDA UDI
Healix Knotless Br 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 3d9190a0-1fe8-4462-a88b-71d1a3642488 38 fields · synced Jun 8, 2026