Identity
- Trade Name
- MEGA PLUS SPINE SYSTEM FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Pre-bent Rod(CoCr), Ø6.0 x 160mm FDA UDI
- Model / Reference
- 61321-160 FDA UDI
- Description
- Pre-bent Rod(CoCr), Ø6.0 x 160mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809665581310 FDA UDI
- 510(k) Number
- K183080 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system rod 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
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
Category: Bone-screw internal spinal fixation system rod
Mega Plus Spine System by Bk Meditech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system rod.
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
- Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
Cleared under the same submission
K183080 also covers:
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD.
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD.
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD.
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD.
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD.
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD.
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD.
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD.
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD.
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD.
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD.
- MEGA PLUS SPINE SYSTEM — BK MEDITECH 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
- Bk Meditech Co., Ltd.
Sources (1)
- FDA UDI d693c359-bfd3-47cd-87dc-986ac76c7d3f 34 fields · synced Jun 8, 2026