FDA.reportPublic FDA data

Drill

Primary DI
06938695521026
Brand
Drill
Company
Shanghai Kinetic Medical Co., Ltd.
Model
FG2100
Published
2025-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113742000KMC KYPHOPLASTY SYSTEMShanghai Kinetic Medical Co., Ltd.2012-09-17NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938695521026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938695521026069386955210266938695521026

GMDN Terms#

Term, Definition table
TermDefinition
Bone access channel kitA collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
528198569
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938695502155Bone DrillFG27012025-12-09
06938695502254CannulaFG22032025-12-09
06938695527004Bone DrillFG27002025-12-09
06938695522009CannulaFG2200FG22002016-12-05
06938695524003DilatorFG2400FG24002016-12-05
06938695530066Puncture NeedleFG3006FG30062016-05-26
06938695537676Dilator w/CannulaFG2410FG24102020-05-31
06938695546067KMC Guide Wire, 1.6mm, Blunt TipKMC-000-002020-10-01
06938695546074KMC Guide Wire, 1.6mm, Sharp TipKMC-000-102020-10-01
06938695546081KMC Access Needle, 11 Gauge, 95mm, Bevel TipKMC-001-002020-10-01
06938695546098KMC Access Needle, 11 Gauge, 95mm, Pyramid TipKMC-001-102020-10-01
06938695546104KMC Access Needle, 11 Gauge, 115mm, Pyramid TipKMC-001-112020-10-01
06938695546111KMC Access Needle, 11 Gauge, 115mm, Integrated Diamond TipKMC-001-202020-10-01
06938695546128KMC Access Needle, 11 Gauge, 115mm, Integrated Bevel TipKMC-001-302020-10-01
06938695546135KMC Access Needle, 13 Gauge, 95mm, Pyramid TipKMC-002-002020-10-01
06938695546142KMC Access Needle, 13 Gauge, 115mm, Pyramid TipKMC-002-012020-10-01
06938695546159KMC Access Needle, 13 Gauge, 115mm, Integrated Bevel TipKMC-002-102020-10-01
06938695546166KMC Balloon Catheter, 8 Gauge, 10mmKMC-003-102020-10-01
06938695546173KMC Balloon Catheter, 8 Gauge, 15mmKMC-003-152020-10-01
06938695546180KMC Balloon Catheter, 8 Gauge, 20mmKMC-003-202020-10-01

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Primary DI, Brand, Company table
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00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
08809281659387BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2026-05-11
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08809281659370BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
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08800038057913MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057920MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057937MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057944MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
07613327554649OmnicurveSTRYKER CORPORATIONHRX2023-11-02
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08800038056312SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
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