Identity
- Trade Name
- Orbitum Staple System FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- 0.90 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT FDA UDI
- Model / Reference
- Rev A FDA UDI
- Description
- 0.90 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT FDA UDI
Identifiers
- Catalog Number
- FO-2013-096 FDA UDI
- Primary DI / UDI-DI
- B565FO20130960 FDA UDI
- 510(k) Number
- K173693 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Orthopaedic bone wire 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone wire
Orbitum Staple System by CPM Medical Consultants, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone wire.
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- SMOOTH K-WIRE, DOUBLE END TROCAR POINT — Biomet Orthopedics, Inc. · Class II
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- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
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Cleared under the same submission
K173693 also covers:
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
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
- CPM Medical Consultants, LLC
Sources (1)
- FDA UDI fe1539dd-8d4e-4d4d-ac49-aa7e1dca8ce2 36 fields · synced May 30, 2026