Identity
- Trade Name
- Y-KNOT FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- Y-KNOT FLEX HIP 1.3 MM ALL SUTURE ANCHOR WITH ONE #2 WHITE/BLACK (5 METRIC) HI-FI SUTURE FDA UDI
- Model / Reference
- YH01 FDA UDI
- Description
- Y-KNOT FLEX HIP 1.3 MM ALL SUTURE ANCHOR WITH ONE #2 WHITE/BLACK (5 METRIC) HI-FI SUTURE FDA UDI
Identifiers
- Catalog Number
- YH01 FDA UDI
- Primary DI / UDI-DI
- 20845854042004 FDA UDI
- 510(k) Number
- K111779 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
Dimensions & Sizes
- Size
- Outer Diameter — 1.3 Millimeter FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Y-Knot by Conmed Corporation — 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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- OrthoButton AL — RIVERPOINT MEDICAL LLC · Class II
Cleared under the same submission
K111779 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
- Conmed Corporation
Sources (1)
- FDA UDI e8c0bf38-363e-49e8-8e41-170f678ae749 38 fields · synced May 30, 2026