Identity
- Trade Name
- Grappler Suture Anchor System FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Knotless Anchor, 4.5mm PEEK + Bridgeline Tape, Sterile Procedure Kit FDA UDI
- Model / Reference
- P44-300-4515-SK FDA UDI
- Description
- Knotless Anchor, 4.5mm PEEK + Bridgeline Tape, Sterile Procedure Kit FDA UDI
Identifiers
- Catalog Number
- P44-300-4515-SK FDA UDI
- Primary DI / UDI-DI
- 00889795124258 FDA UDI
- 510(k) Number
- K211002 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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
Category: General internal orthopaedic fixation system implantation kit
Grappler Suture Anchor System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K211002 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
- Paragon 28
Sources (1)
- FDA UDI 178eb0f0-d2ab-4018-b31b-2dcbe06d9340 35 fields · synced May 30, 2026