FDA.reportPublic FDA data

Stylet, 285mm

Primary DI
00816950027949
Brand
Stylet, 285mm
Company
Osteocentric Technologies, Inc.
Model
2004-0011
Catalog number
2004-0011
Device description
Stylet, 285mm
Published
2020-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAHStylet, Surgical, General & Plastic Surgery
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAHStylet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170021000SMV Scientific Cannulated ScrewsSmv Scientific2017-05-22HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816950027949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816950027949008169500279498169500279490816950027949

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail guidewire, single-useA sterile, long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length285Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1800-969-0639info@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
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00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
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B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03