FDA.report

MEGA PLUS SPINE SYSTEM

Primary DI
08809763500299
Brand
MEGA PLUS SPINE SYSTEM
Company
BK MEDITECH CO.,LTD.
Model
51750-20
Device description
Rod Forceps
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
HXKHolder, Needle; Orthopedic

Product Code Classifications

CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809763500299PrimaryGS10

GMDN Terms

TermDefinition
Surgical implant handling forcepsA hand-held manual surgical instrument with blades designed to grasp and manipulate a surgical implant (excluding sutures) during implantation; it is not intended for use on tissues, is not a dental or ophthalmic device, and is not a dedicated tissue clip applier. It is made of metal materials and may have one of various designs (e.g., tweezers-, scissors-, alligator-like) whereby the blades are designed to be opened/closed to handle a variety of implantable devices (e.g., orthopaedic joint prosthesis, breast implant, surgical mesh). This is a reusable device intended to be sterilized prior to use.

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

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04058749027327NAFehling Instruments GmbH & Co. KGHXK2026-03-05
04058749027457NAFehling Instruments GmbH & Co. KGHXK2026-03-05
04058749028102NAFehling Instruments GmbH & Co. KGHXK2026-03-05
00810158218772PRINCETONPrinceton Medical Group, Inc.HXK2026-02-05
00810158218819PRINCETONPrinceton Medical Group, Inc.HXK2026-02-05
B356DF370170American MedicalsAmerican MedicalsHXK2026-01-30
04058749027990NAFehling Instruments GmbH & Co. KGHXK2026-01-28
04058749028003NAFehling Instruments GmbH & Co. KGHXK2026-01-28
00840217910125Wiggins medicalEbner Medical, LLCHXK2025-12-10
00840217910163Wiggins medicalEbner Medical, LLCHXK2025-12-10
04058749026764NAFehling Instruments GmbH & Co. KGHXK2025-12-08
04058749027471NAFehling Instruments GmbH & Co. KGHXK2025-12-08
04058749027495NAFehling Instruments GmbH & Co. KGHXK2025-12-08
04058749119695NAFehling Instruments GmbH & Co. KGHXK2025-12-08
09348811016287INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-12-02
00757770676446Bausch + LombBausch & Lomb IncorporatedHXK2025-11-14
00841336107632Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHXK2025-09-28
00840314270078gSourceGSOURCE LLCHXK2025-09-21
00810158217065PRINCETONPrinceton Medical Group, Inc.HXK2025-09-18
00810158216792PRINCETONPrinceton Medical Group, Inc.HXK2025-09-02
04058749028232NAFehling Instruments GmbH & Co. KGHXK2025-09-01
04058749026771NAFehling Instruments GmbH & Co. KGHXK2025-08-29
00840217909822Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909839Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909853Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909860Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909884Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909907Wiggins medicalEbner Medical, LLCHXK2025-08-20