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Monkey Bars™ Pin to Bar External Fixation System
FDA UDIClass II (US FDA UDI)
by Paragon 28
Identity
- Trade Name
- Monkey Bars™ Pin to Bar External Fixation System FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- 4mm x 30mm Half Pin (Self Tapping) FDA UDI
- Model / Reference
- P47-210-430S FDA UDI
- Description
- 4mm x 30mm Half Pin (Self Tapping) FDA UDI
Identifiers
- Catalog Number
- P47-210-430S FDA UDI
- Primary DI / UDI-DI
- 00889795114594 FDA UDI
- 510(k) Number
- K211112 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use 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
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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: External orthopaedic fixation system, single-use
Monkey Bars™ Pin to Bar External Fixation System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, single-use.
- TRUELOK EVO — Orthofix, Inc. · Class II
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- TrueLok — Orthofix, Inc. · Class II
- ARBOR — GLOBUS MEDICAL, INC. · Class II
- DRACO — HNM TOTAL RECON LLC · Class II
- PREFIX FIXATOR — Orthofix, Inc. · Class II
- RINGFIX — Stryker Corp. · Class II
- SMART TSF — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K211112 also covers:
- Monkey Bars™ Pin to Bar External Fixation System — Paragon 28
- Monkey Bars™ Pin to Bar External Fixation System — Paragon 28
- Monkey Bars™ Pin to Bar External Fixation System — Paragon 28
- Monkey Bars™ Pin to Bar External Fixation System — Paragon 28
- Monkey Bars™ Pin to Bar External Fixation System — Paragon 28
- Monkey Bars™ Pin to Bar External Fixation System — Paragon 28
- Monkey Bars™ Pin to Bar External Fixation System — Paragon 28
- Monkey Bars™ Pin to Bar External Fixation System — Paragon 28
- Monkey Bars™ Pin to Bar External Fixation System — Paragon 28
- Monkey Bars™ Pin to Bar External Fixation System — Paragon 28
- Monkey Bars™ Pin to Bar External Fixation System — Paragon 28
- Monkey Bars™ Pin to Bar External Fixation 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 b3db15fe-ca97-4cc8-abe7-d6fea8f3dd7c 35 fields · synced Jun 8, 2026