Identity
- Trade Name
- Hedjet System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Hedjet 13mm Reduction Cannulated Poly axial Screw 8.5x105mm, Ø5.5mm Rod FDA UDI
- Model / Reference
- 13DZRCPS85105 FDA UDI
- Description
- Hedjet 13mm Reduction Cannulated Poly axial Screw 8.5x105mm, Ø5.5mm Rod FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809974007143 FDA UDI
- 510(k) Number
- K232218 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal bone screw, non-bioabsorbable
Hedjet System by Medyssey Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
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- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Cleared under the same submission
K232218 also covers:
- Hedjet System — Medyssey Co., Ltd.
- Hedjet System — Medyssey Co., Ltd.
- Hedjet System — Medyssey Co., Ltd.
- Hedjet System — Medyssey Co., Ltd.
- Hedjet System — Medyssey Co., Ltd.
- Hedjet System — Medyssey Co., Ltd.
- Hedjet System — Medyssey Co., Ltd.
- Hedjet System — Medyssey Co., Ltd.
- Hedjet System — Medyssey Co., Ltd.
- Hedjet System — Medyssey Co., Ltd.
- Hedjet System — Medyssey Co., Ltd.
- Hedjet System — Medyssey Co., Ltd.
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
- Medyssey Co., Ltd.
Sources (1)
- FDA UDI e81a285b-8e4a-440e-9a64-c1dbe1121ca5 34 fields · synced Jun 8, 2026