Identity
- Trade Name
- ICONIX FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- 2.3MM ICONIX 3 ANCHOR W/INTELLIBRAID TECHNOLOGY 3 STRANDS #2 FORCE FIBER FDA UDI
- Model / Reference
- 3910-500-532 FDA UDI
- Description
- 2.3MM ICONIX 3 ANCHOR W/INTELLIBRAID TECHNOLOGY 3 STRANDS #2 FORCE FIBER FDA UDI
Identifiers
- Catalog Number
- 3910-500-532 FDA UDI
- Primary DI / UDI-DI
- 07613252450368 FDA UDI
- 510(k) Number
- K133671 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
MR Safe FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Iconix by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
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- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K133671 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
- Stryker Corp.
Sources (1)
- FDA UDI bc19bb00-8278-45e2-982a-310f33dfbdb7 37 fields · synced May 30, 2026