Identity
- Trade Name
- Asfora Anterior Cervical Plate System FDA UDI
- Generic Name
- Manual surgical rotary handpiece, reusable FDA UDI
- Device Name
- Axial Driver Handle FDA UDI
- Model / Reference
- 11-1106-FD43 FDA UDI
- Description
- Axial Driver Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- M364111106FD430 FDA UDI
- 510(k) Number
- K143688 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Manual surgical rotary handpiece, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Manual surgical rotary handpiece, reusable
Asfora Anterior Cervical Plate System by Medical Designs Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual surgical rotary handpiece, reusable.
- RENOIR Posterior Cervico-Thoracic Fixation System — CTL Medical Corporation · Class I
- MANUAL HANDPIECE DRIVER, FITS LATCH CONNECT 1:1 RATIO — W.H. Holden, Inc. · Class I
- Invivo — Philips DS North America LLC · Class II
- GII — Medos International Sàrl · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- HNM Medical — HNM STAINLESS, LLC. · Class I
- HALLMARK — Orthofix US LLC · Class I
- CHESAPEAKE Stabilization System — K2M, INC. · Class I
Cleared under the same submission
K143688 also covers:
- Asfora Anterior Cervical Plate System — MEDICAL DESIGNS LLC
- Asfora Anterior Cervical Plate System — MEDICAL DESIGNS LLC
- Asfora Anterior Cervical Plate System — MEDICAL DESIGNS LLC
- Asfora Anterior Cervical Plate System — MEDICAL DESIGNS LLC
- Asfora Anterior Cervical Plate System — MEDICAL DESIGNS LLC
- Asfora Anterior Cervical Plate System — MEDICAL DESIGNS LLC
- Asfora Anterior Cervical Plate System — MEDICAL DESIGNS LLC
- Asfora Anterior Cervical Plate System — MEDICAL DESIGNS LLC
- Asfora Anterior Cervical Plate System — MEDICAL DESIGNS LLC
- Asfora Anterior Cervical Plate System — MEDICAL DESIGNS LLC
- Asfora Anterior Cervical Plate System — MEDICAL DESIGNS LLC
- Asfora Anterior Cervical Plate System — MEDICAL DESIGNS LLC
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
- Medical Designs Llc
Sources (1)
- FDA UDI 28e7ded5-a49d-4928-bdd1-9d60d8d2a177 34 fields · synced Jun 1, 2026