Identity
- Trade Name
- OIC External Fixation System FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- 4MM X 30MM BLUNT TIPPED HALF PIN FDA UDI
- Model / Reference
- BLHP-0430 FDA UDI
- Description
- 4MM X 30MM BLUNT TIPPED HALF PIN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811998038275 FDA UDI
- 510(k) Number
- K171211 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.0 Millimeter FDA UDILength — 150 Millimeter FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
OIC External Fixation System by Orthopaedic Implant Company, The — 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
K171211 also covers:
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
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
- Orthopaedic Implant Company, The
Sources (1)
- FDA UDI 5932ebe9-b7c5-45eb-ba70-131eb2818e53 36 fields · synced May 30, 2026