Identity
- Trade Name
- Grappler Interference Screw System FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- Ø4.5/5.0 Driver, Cannulated FDA UDI
- Model / Reference
- P41-941-4550 FDA UDI
- Description
- Ø4.5/5.0 Driver, Cannulated FDA UDI
Identifiers
- Catalog Number
- P41-941-4550 FDA UDI
- Primary DI / UDI-DI
- 00889795106315 FDA UDI
- 510(k) Number
- K183690 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Fluted surgical drill bit, single-use
Grappler Interference Screw 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
K183690 also covers:
- Grappler Interference Screw System — Paragon 28
- Grappler Interference Screw System — Paragon 28
- Grappler Interference Screw System — Paragon 28
- Grappler Interference Screw System — Paragon 28
- Grappler Interference Screw System — Paragon 28
- Grappler Interference Screw System — Paragon 28
- Grappler Interference Screw System — Paragon 28
- Grappler Interference Screw System — Paragon 28
- Grappler Interference Screw System — Paragon 28
- Grappler Interference Screw System — Paragon 28
- Grappler Interference Screw System — Paragon 28
- Grappler Interference Screw System — Paragon 28
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 dbcbfded-d218-4b6a-abd0-8c5677b5b1d4 35 fields · synced May 30, 2026