Identity
- Trade Name
- UNIMAX FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system sterilization container/implant set FDA UDI
- Device Name
- BONE SCREW 5.5 MM X 45 MM FDA UDI
- Model / Reference
- 110-5545 FDA UDI
- Description
- BONE SCREW 5.5 MM X 45 MM FDA UDI
Identifiers
- Catalog Number
- 110-5545 FDA UDI
- Primary DI / UDI-DI
- 00852647007016 FDA UDI
- 510(k) Number
- K014302 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system sterilization container/implant set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 45 Millimeter FDA UDIOuter Diameter — 5.5 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system sterilization container/implant set
Unimax by Paramount Surgicals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K014302 also covers:
- UNIMAX — PARAMOUNT SURGICALS, INC.
- UNIMAX — PARAMOUNT SURGICALS, INC.
- UNIMAX — PARAMOUNT SURGICALS, INC.
- UNIMAX — PARAMOUNT SURGICALS, INC.
- UNIMAX — PARAMOUNT SURGICALS, INC.
- UNIMAX — PARAMOUNT SURGICALS, INC.
- UNIMAX — PARAMOUNT SURGICALS, INC.
- UNIMAX — PARAMOUNT SURGICALS, INC.
- UNIMAX — PARAMOUNT SURGICALS, INC.
- UNIMAX — PARAMOUNT SURGICALS, INC.
- UNIMAX — PARAMOUNT SURGICALS, INC.
- UNIMAX — PARAMOUNT SURGICALS, INC.
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
- Paramount Surgicals, Inc.
Sources (1)
- FDA UDI 92e58572-975c-405d-b78e-f706650c2ad0 37 fields · synced May 30, 2026