Identity
- Trade Name
- TruShot FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- TruShot™ with Y-Knot® 1.3 mm All-Suture Anchor with one #2 (5 metric) Hi-Fi® Suture with Needles FDA UDI
- Model / Reference
- Y13TN FDA UDI
- Description
- TruShot™ with Y-Knot® 1.3 mm All-Suture Anchor with one #2 (5 metric) Hi-Fi® Suture with Needles FDA UDI
Identifiers
- Catalog Number
- Y13TN FDA UDI
- Primary DI / UDI-DI
- 30845854850064 FDA UDI
- 510(k) Number
- K182446 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
TruShot by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K182446 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 c3fd0082-d5b3-4e05-8172-07e8dab40331 38 fields · synced May 30, 2026