FDA.reportPublic FDA data

5.0 X 60MM DRILL SLEEVE

Primary DI
00816950029752
Brand
5.0 X 60MM DRILL SLEEVE
Company
Osteocentric Technologies, Inc.
Model
303-5002
Catalog number
303-5002
Device description
5.0 X 60MM DRILL SLEEVE
Published
2022-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160603000SMV Scientific Schanz ScrewsSmv Scientific2016-03-28HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816950029752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816950029752008169500297528169500297520816950029752

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, single-useA sterile, hand-held surgical tubular device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw) and/or facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, to stabilize an instrument/implant coupling, and/or to protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Millimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-969-0639quality@osteocentric.com

Regulatory Flags#

DUNS number
089645059
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008100978037493.0mm GUIDE WIRE 355mm202-80600202-806002026-06-02
00810118210198Torque Wrench701-0019701-00192023-10-31
00810118210259.050 Driver, Short701-0025701-00252023-10-31
00810118210266.050 Driver, Long701-0026701-00262023-10-31
00810118210273.050 Driver, Latch701-0027701-00272023-10-31
00810118210280Thumb Knob701-0029701-00292023-10-31
00810118210327Latch Driver, 300 Series701-0033701-00332023-10-31
00810118210334Square Driver, 300 Series701-0034701-00342023-10-31
00810118210341Latch Driver, 400 Series701-0035701-00352023-10-31
00810118210358Square Driver, 400 Series701-0036701-00362023-10-31
00810118210365Ratchet Adapter701-0037701-00372023-10-31
008101182100063.7mm Tap701-0013701-00132023-10-30
008101182100134.2mm Tap701-0014701-00142023-10-30
008101182100205.5mm Tap701-0015701-00152023-10-30
00810118210129Drill Extender701-0009701-00092023-10-30
008101182101673.7mm Parallel Pin701-0016701-00162023-10-30
008101182101744.2mm Parallel Pin701-0017701-00172023-10-30
008101182101815.5mm Parallel Pin701-0018701-00182023-10-30
00810097803527NAV 3.5mm DRILL104-0003104-00032026-03-26
00810097803534NAV TAPERED PROBE104-0005104-00052026-03-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337121657Working Tube with long lipJoimax GmbHFZX2026-08-19
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06936666566724CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06936666566731CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278653161CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278653321CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278653475CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278653499CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278654793CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278654809CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
00810111225427TargeterTreace Medical Concepts, Inc.FZX2026-08-14
00810111225434TargeterTreace Medical Concepts, Inc.FZX2026-08-14
00850088713541PRINCETONPrinceton Medical Group, Inc.MDM2026-08-14
00190776411091MillenniumAvalign Technologies, Inc.FZX2026-08-07
00190776411534MillenniumAvalign Technologies, Inc.MDM2026-08-07
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06438408012815Inion CompressOn™ / Inion FreedomScrew™ InstrumentInion OyFZX2026-08-07
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06438408012839Inion CompressOn™ InstrumentInion OyFZX2026-08-07
B382SD923286060Surgical DirectSurgical Direct, Inc.MDM2026-08-07
00190776422806MillenniumAvalign Technologies, Inc.MDM2026-08-03
00840606191838Overwatch PCFSPINAL ELEMENTS, INC.FZX2026-07-31
00840606191845Overwatch PCFSPINAL ELEMENTS, INC.FZX2026-07-31
00190376544496InvictusALPHATEC SPINE, INC.FZX2026-07-30
00198506092350ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506093197ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
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03701089528054AMPLITUDEAMPLITUDE SASFZX2026-07-29