Identity
- Trade Name
- Bone Acess Needle FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- Bone Access Needle 11ga x 6in FDA UDI
- Model / Reference
- FS-DBANJ1106TL FDA UDI
- Description
- Bone Access Needle 11ga x 6in FDA UDI
Identifiers
- Catalog Number
- FS-DBANJ1106TL FDA UDI
- Primary DI / UDI-DI
- B183FSDBANJ1106TL0 FDA UDI
- 510(k) Number
- K141850 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Bone access cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone access cannula
Bone Acess Needle by Flospine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone access cannula.
- BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length — Tecres · Class I
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- Stryker — Provision · Class I
- Omnia Medical PsiF — Omnia Medical · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Omnia Medical Instruments — Omnia Medical · Class I
- Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY LLC · Class II
- Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY LLC · Class II
Cleared under the same submission
K141850 also covers:
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
- Flospine
Sources (1)
- FDA UDI c1fa563e-4166-4f29-94c6-a1155d9e33a5 37 fields · synced May 30, 2026