Identity
- Trade Name
- 4.0 Super Fastener Screw Tap, 200mm FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- 4.0 Super Fastener Screw Tap, 200mm FDA UDI
- Model / Reference
- 321-0007 FDA UDI
- Description
- 4.0 Super Fastener Screw Tap, 200mm FDA UDI
Identifiers
- Catalog Number
- 321-0007 FDA UDI
- Primary DI / UDI-DI
- 00810074301732 FDA UDI
- 510(k) Number
- K150981 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDI
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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
Dimensions & Sizes
- Size
- Outer Diameter — 4.0 Millimeter FDA UDILength — 200 Millimeter FDA UDI
Category: Bone tap, reusable
4.0 Super Fastener Screw Tap, 200mm by OsteoCentric Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone tap, reusable.
- BIOSURE — Smith & Nephew, Inc. · Class I
- NobelActive® — Nobel Biocare AG · Class I
- CORTICAL TAP — Biomet Orthopedics, Inc. · Class I
- PressON™ — NEXUS SPINE, L.L.C. · Class I
- Insite — TORNIER, INC. · Class I
- ReLine — Nuvasive, Inc. · Class I
- Mariner MIS — SeaSpine Orthopedics Corporation · Class I
- Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · Class I
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 b28d5354-54aa-420d-9139-edd4e12ba8da 37 fields · synced Jun 8, 2026