Identity
- Trade Name
- OIC Intramedullary Nail System FDA UDI
- Generic Name
- Orthopaedic ball spike FDA UDI
- Device Name
- BALL SPIKE PUSHER FDA UDI
- Model / Reference
- 01-IM53 FDA UDI
- Description
- BALL SPIKE PUSHER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811998036516 FDA UDI
- 510(k) Number
- K181184 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic ball spike FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic ball spike
OIC Intramedullary Nail System by Orthopaedic Implant Company, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic ball spike.
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- Bone Spike, Straight — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- SMR Shoulder — Limacorporate · Class II
- SMR Shoulder — Limacorporate · Class II
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Cleared under the same submission
K181184 also covers:
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail 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 96bc2a9e-48b0-4bfa-ac35-0a817e09982e 35 fields · synced May 30, 2026