Identity
- Trade Name
- 3.5mm Screw Fastener Self-Tapping 130mm FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 3.5mm Screw Fastener Self-Tapping 130mm FDA UDI
- Model / Reference
- 335-1130 FDA UDI
- Description
- 3.5mm Screw Fastener Self-Tapping 130mm FDA UDI
Identifiers
- Catalog Number
- 335-1130 FDA UDI
- Primary DI / UDI-DI
- 00816950025129 FDA UDI
- 510(k) Number
- K150981 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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 — 130 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
3.5mm Screw Fastener Self-Tapping 130mm by OsteoCentric Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
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- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
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- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K150981 also covers:
- 13mm washer 1.5mm Height — OsteoCentric Technologies,Inc
- 2.7 mm Interlocking Bone Screw Fastener — OsteoCentric Technologies,Inc
- 2.7mm Interlocking Bone Screw Fastener — OsteoCentric Technologies,Inc
- 2.7mm Interlocking Bone Screw Fastener — OsteoCentric Technologies,Inc
- 2.7mm Interlocking Bone Screw Fastener — OsteoCentric Technologies,Inc
- 2.7mm Interlocking Bone Screw Fastener — OsteoCentric Technologies,Inc
- 3.3mm Screw Fastener Self Tapping 14mm — OsteoCentric Technologies,Inc
- 3.3mm Screw Fastener Self Tapping 16mm — OsteoCentric Technologies,Inc
- 3.3mm Screw Fastener Self Tapping 22mm — OsteoCentric Technologies,Inc
- 3.3mm Screw Fastener Self Tapping 40mm — OsteoCentric Technologies,Inc
- 3.5mm Screw Fastener Self-Tapping 100mm — OsteoCentric Technologies,Inc
- 3.5mm Screw Fastener Self-Tapping 10mm — OsteoCentric Technologies,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 |
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Manufacturer
- Manufacturer
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI 189e0616-000c-4eda-aef9-125e83d2c4b8 37 fields · synced Jun 8, 2026