Identity
- Trade Name
- Black Diamond Pedicle Screw System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy. FDA UDI
- Model / Reference
- 1001-0000 FDA UDI
- Description
- The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy. FDA UDI
Identifiers
- Catalog Number
- 1001-0000 to 1010-9999 FDA UDI
- Primary DI / UDI-DI
- B062100100000J FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile 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
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
Dimensions & Sizes
- Size
- Length — 300 Millimeter FDA UDILength — 250 Millimeter FDA UDILength — 200 Millimeter FDA UDILength — 120 Millimeter FDA UDILength — 115 Millimeter FDA UDILength — 110 Millimeter FDA UDILength — 105 Millimeter FDA UDILength — 40 Millimeter FDA UDILength — 35 Millimeter FDA UDILength — 30 Millimeter FDA UDIOuter Diameter — 8.5 Millimeter FDA UDIOuter Diameter — 7.5 Millimeter FDA UDIOuter Diameter — 6.5 Millimeter FDA UDIOuter Diameter — 5.5 Millimeter FDA UDIOuter Diameter — 4.5 Millimeter FDA UDIDepth — 90 Millimeter FDA UDIDepth — 70 Millimeter FDA UDIDepth — 50 Millimeter FDA UDIDepth — 35 Millimeter FDA UDIDepth — 30 Millimeter FDA UDILength — 45 Millimeter FDA UDILength — 50 Millimeter FDA UDILength — 55 Millimeter FDA UDILength — 60 Millimeter FDA UDILength — 65 Millimeter FDA UDILength — 70 Millimeter FDA UDILength — 75 Millimeter FDA UDILength — 80 Millimeter FDA UDILength — 85 Millimeter FDA UDILength — 90 Millimeter FDA UDILength — 95 Millimeter FDA UDILength — 100 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system, non-sterile
Black Diamond Pedicle Screw System by Osseus Fusion Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, non-sterile.
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- Vitality® — BIOMET SPINE LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- PASS LP — Medicrea International SA · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
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
- Osseus Fusion Systems Llc
Sources (1)
- FDA UDI e756f3cc-63df-4aba-b7b3-e5ed0820bc3b 35 fields · synced May 29, 2026