FDA.reportPublic FDA data

OTIS-C-PLUS

Primary DI
03760154001014
Brand
OTIS-C-PLUS
Company
S.B.M
Model
Drill guide
Catalog number
EVO9069428
Device description
Drill guide for use with OTIS-C-PLUS osteosynthesis plates for HTO.
Published
2023-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760154001014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760154001014037601540010143760154001014

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
772462123
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760154001083OTISImpactor bodyEVO90694442023-12-19
03760154001090OTISImpactor tipEVO90694462023-12-19
03760304681738LIGAFIX / PULLUPPin Set PULLIG90032025-12-11
03760304681745LIGAFIXPin Set LIG90000042025-12-11
03760304681752LIGAFIXPin Set LIG90000052025-12-11
03760304681776PULLUPPin Set PULLUP90082025-12-11
03760304681592PULLUPReusable suture retriever pin x5PUL90053032025-12-10
03760304681608PULLUPReusable suture retriever pin x10PUL90103032025-12-10
03760304681615ecoPass LSuture passer automatic grasper Large (Shoulder)EPA90004542025-06-26
03760304681622ecoPass SSuture passer automatic grasper - KneeMEN90004552025-06-26
03760304681639ecoPassNon sterile needle (x1)ANS90014612025-06-26
03760304681646ecoPassNon sterile needle (x5)ANS90054612025-06-26
03760304681653ecoPassNon sterile needle (x10)ANS90104612025-06-26
03760304681769BTLOOPPin Set PULLIG90072025-11-20
03760154006224OTIS-C-PLUSDrill bitEVO90351002023-12-21
03760154006248OTIS-C-PLUSCountersink bitEVO90402032023-12-21
03760304680045RetroTechDrill bitLIG90002942023-12-21
03760154003704PULLUPReusable suture retriever pin x1PUL90003032023-12-20
03760154005791LIGAFIXDrill bitLIG9009289 2023-12-20
03760154005814LIGAFIXRouter bitLIG90100722023-12-20

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08809986489784LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489791LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
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