FDA.reportPublic FDA data

Spine Instruments

Primary DI
07630040712606
Brand
Spine Instruments
Company
Medacta International SA
Model
03.52.10.1202
Device description
Bifurcated surgical illuminator, STERILE
Published
2020-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FDGRetractor, Fiberoptic
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDGRetractor, FiberopticGastroenterology, Urology1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630040712606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630040712606076300407126067630040712606

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
488227125
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630345700551NextAR TSA Platform5.3KSWNXAR2026-07-10
07630345729316NextAR TSA Platform5.3SSWNXAR2026-04-13
07630345728975Navigation System for Knee surgery33.22.10002026-01-26
07630699701792Navigation System for Knee surgery33.22.1000US2026-01-26
07630345725912NextAR Spine Platform98.46.NEXTAR2026-01-20
07630542722332NextAR Hip Platform09.23.10.IMU2026-01-14
07630542779626NextAR Hip Platform5.3HSWNXAR2026-01-14
07630542759130NextAR™ Spine03.57.10.02622025-11-14
07630542759147NextAR™ Spine03.57.10.02632025-11-14
07630542720390NextAR Spine Platform03.57.10.02032025-09-19
07630542720406NextAR Spine Platform03.57.10.02042025-09-19
07630542720413NextAR Spine Platform03.57.10.02052025-09-19
07630542720420NextAR Spine Platform03.57.10.02062025-09-19
07630542720437NextAR Spine Platform03.57.10.02072025-09-19
07630542720444NextAR Spine Platform03.57.10.02082025-09-19
07630542720451NextAR Spine Platform03.57.10.02092025-09-19
07630542765346NextAR (TM) Shoulder Platform04.01.10.09022025-09-17
07630542765353NextAR (TM) Shoulder Platform04.01.10.09032025-09-17
07630542765360NextAR (TM) Shoulder Platform04.01.10.09042025-09-17
07630542765421NextAR (TM) Shoulder Platform04.01.10.09102025-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327697209PANGEAStryker GmbHLXH2026-08-27
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00840606186018ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186032ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186056ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186063ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186070ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186087ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186094ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186117ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186124ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186131ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186148ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186155ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186162ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186179ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186193ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186209ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186247ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186254ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186414ALIFSPINAL ELEMENTS, INC.LXH2026-08-26