FDA.report

MEGA PLUS SPINE SYSTEM

Primary DI
08809763500084
Brand
MEGA PLUS SPINE SYSTEM
Company
BK MEDITECH CO.,LTD.
Model
51640-08
Device description
Awl
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HWJAwl

Product Code Classifications

CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809763500084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809763500084088097635000848809763500084

GMDN Terms

TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
687941818
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08809763492273MEGA PLUS MIS SPINE SYSTEM14318-302025-05-21
08809763492280MEGA PLUS MIS SPINE SYSTEM14318-402025-05-21
08809763492297MEGA PLUS SPINE SYSTEM124602025-05-21
08809763492440MEGA PLUS SPINE SYSTEM124702025-05-21
08809665582867MEGA PLUS MIS SPINE SYSTEM69185-852020-09-18
08809665584281MEGA PLUS MIS SPINE SYSTEM69250-552020-09-18
08809665584762MEGA PLUS MIS SPINE SYSTEM69285-852020-09-18
08809155852319MEGA PLUS SPINE SYSTEM61120-0352018-03-23
08809155852326MEGA PLUS SPINE SYSTEM61120-0452018-03-23
08809155852333MEGA PLUS SPINE SYSTEM61120-222018-03-23
08809155852340MEGA PLUS SPINE SYSTEM61120-242018-03-23
08809155852357MEGA PLUS SPINE SYSTEM61120-262018-03-23
08809155852364MEGA PLUS SPINE SYSTEM61120-282018-03-23
08809155857109MEGA PLUS SPINE SYSTEM61120-142018-03-23
08809155857116MEGA PLUS SPINE SYSTEM61120-152018-03-23
08809155857130MEGA PLUS SPINE SYSTEM61120-172018-03-23
08809155857147MEGA PLUS SPINE SYSTEM61120-182018-03-23
08809155857154MEGA PLUS SPINE SYSTEM61120-192018-03-23
08809155857178MEGA PLUS SPINE SYSTEM61120-252018-03-23
08809155857185MEGA PLUS SPINE SYSTEM61120-302018-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840311262854CONTACT ALPXtant Medical Holdings, Inc.HWJ2026-03-20
06974940306772endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306857endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306864endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306918endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
00199150066889Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-03-02
00190376709246AMP IIALPHATEC SPINE, INC.HWJ2026-02-18
00860015151322EnFix Instrument Kit - TACTETROUS, INC.HWJ2026-02-11
10886982361288NASynthes GmbHHWJ2026-02-11
00860014213427Awl - Non-CuttingTETROUS, INC.HWJ2026-02-10
00860014213434Cutting Awl - 5.5mmTETROUS, INC.HWJ2026-02-10
00860014213441Cutting Awl - 4.5mmTETROUS, INC.HWJ2026-02-10
00888480489818Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480489825Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480489832Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480597001Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480597018Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480610847Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480610861Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480610878Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00190376680422ProximityALPHATEC SPINE, INC.HWJ2025-12-19
10889981162252Vu a POD™ Prime NanoMetaleneSeaspine Orthopedics CorporationHWJ2025-12-19
10889981162269Vu a POD™ Prime NanoMetaleneSeaspine Orthopedics CorporationHWJ2025-12-19
03662663242929Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663242950Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243018Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243117Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243209Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243216Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663244725Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWJ2025-12-18