Identity
- Trade Name
- JAWS Staple System FDA UDI
- Generic Name
- Cannulated surgical drill guiding pin FDA UDI
- Device Name
- JAW STAPLE SYS, SMOOTH LOC PIN FDA UDI
- Model / Reference
- P70-294-2006 FDA UDI
- Description
- JAW STAPLE SYS, SMOOTH LOC PIN FDA UDI
Identifiers
- Catalog Number
- P70-294-2006 FDA UDI
- Primary DI / UDI-DI
- 00889795114143 FDA UDI
- 510(k) Number
- K170923 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Cannulated surgical drill guiding pin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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: Cannulated surgical drill guiding pin
JAWS Staple System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannulated surgical drill guiding pin.
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- MEDLINE UNITE — MEDLINE INDUSTRIES, INC. · Class I
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- CONQUEST FN — Smith & Nephew, Inc. · Class II
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- Superhawk — RESPONSIVE ORTHOPEDICS LLC · Class I
- GUIDE PIN 2.8 BL & 3.2 PL — Biomet Orthopedics, Inc. · Class II
- MEDLINE UNITE — MEDLINE INDUSTRIES, INC. · Class I
Cleared under the same submission
K170923 also covers:
- JAWS Nitinol Staple System — Paragon 28
- JAWS Nitinol Staple System — Paragon 28
- JAWS Nitinol Staple System — Paragon 28
- JAWS Nitinol Staple System — Paragon 28
- JAWS Nitinol Staple System — Paragon 28
- JAWS Nitinol Staple System — Paragon 28
- JAWS Nitinol Staple System — Paragon 28
- JAWS Nitinol Staple System — Paragon 28
- JAWS Staple System — Paragon 28
- JAWS Staple System — Paragon 28
- JAWS Staple System — Paragon 28
- JAWS Staple 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 253b6037-e5ee-44a6-9117-b9965d5bbad4 35 fields · synced May 30, 2026