Identity
- Trade Name
- HammerTube System FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- K-Wire, Double Ended Trocar Tip, 1.6mm x 150mm FDA UDI
- Model / Reference
- P99-292-1615 FDA UDI
- Description
- K-Wire, Double Ended Trocar Tip, 1.6mm x 150mm FDA UDI
Identifiers
- Catalog Number
- P99-292-1615 FDA UDI
- Primary DI / UDI-DI
- 00889795153265 FDA UDI
- 510(k) Number
- K171715 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone pin, 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
HammerTube System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin, non-bioabsorbable.
- Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
- KW03-310-18.A — newbox medical GmbH · Class IIb
- Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
- IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
- XtraFix® External Fixation System — Zimmer, Inc. · Class II
- CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
- SMART TSF — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K171715 also covers:
- HammerTube System — Paragon 28
- HammerTube System — Paragon 28
- HammerTube System — Paragon 28
- HammerTube System — Paragon 28
- HammerTube System — Paragon 28
- HammerTube System — Paragon 28
- HammerTube System — Paragon 28
- HammerTube System — Paragon 28
- HammerTube System — Paragon 28
- HammerTube™ System — Paragon 28
- HammerTube™ System — Paragon 28
- HammerTube™ 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 f144a0c4-713e-480e-9169-c11078765ba8 35 fields · synced Jun 6, 2026