Identity
- Trade Name
- 15mm HALF TAP CANNULATED FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- 15mm HALF TAP CANNULATED FDA UDI
- Model / Reference
- 324-0016 FDA UDI
- Description
- 15mm HALF TAP CANNULATED FDA UDI
Identifiers
- Catalog Number
- 324-0016 FDA UDI
- Primary DI / UDI-DI
- 00810189110441 FDA UDI
- 510(k) Number
- K230764 FDA UDI
- FDA Product Code
- HWX FDA UDI
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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 — 15 Millimeter FDA UDI
Category: Bone tap, reusable
15mm HALF TAP CANNULATED by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone tap, reusable.
- BIOSURE — Smith & Nephew, Inc. · Class I
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- 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
K230764 also covers:
- 11 X 100mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 105mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 110mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 75mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 80mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 85mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 90mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11mm HALF TAP CANNULATED — OsteoCentric Technologies,Inc
- 13 X 100mm LAG FASTENER — OsteoCentric Technologies,Inc
- 13 X 105mm LAG FASTENER — OsteoCentric Technologies,Inc
- 13 X 110mm LAG FASTENER — OsteoCentric Technologies,Inc
- 13 X 115mm LAG FASTENER — 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 I | Pending data |
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Manufacturer
- Manufacturer
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI a06b7c80-f49a-4a83-9cae-bb770252ec3c 37 fields · synced Jun 8, 2026