FDA.reportPublic FDA data

MOUNTAINEER

Primary DI
10705034221854
Brand
MOUNTAINEER
Company
Medos International Sàrl
Model
288314100
Catalog number
288314100
Device description
MOUNTAINEER OCT SPINAL SYSTEM OC COUNTER TORQUE DEVICE
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWRDRIVER, PROSTHESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWRDriver, ProsthesisOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034221854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503422185410705034221854

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
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
10705034165448COUGAR1891555141891555142015-09-24
10705034189017VG22733401002733401002016-12-31
10705034192802SUMMIT2746280002746280002016-12-31
10705034195278DISCOVERY2757200002757200002016-12-31
10705034199368EXPEDIUM2797224602797224602016-12-31
10705034224817UNIPLATE2897110002897110002016-12-31
10705034204246KEYSTONE2821040002821040002016-11-18
10705034060835BENGAL1773061221773061222015-09-24
10705034060866BENGAL1773061281773061282015-09-24
10705034161372COUGAR1891304101891304102015-09-24
10705034162973COUGAR1891404141891404142015-09-24
10705034163345COUGAR1891408121891408122015-09-24
10705034163369COUGAR1891408141891408142015-09-24
10705034163383COUGAR1891408161891408162015-09-24
10705034163499COUGAR1891451141891451142015-09-24
10705034163581COUGAR1891452101891452102015-09-24
10705034163604COUGAR1891452121891452122015-09-24
10705034163628COUGAR1891452141891452142015-09-24
10705034164168COUGAR1891458161891458162015-09-24
10705034164212COUGAR1891501081891501082015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G079C5070000120Golden Isles Pedicle Screw SystemIntelivation, LLCHWR2026-04-22
07640332478462SCARLET® AC-TiSpineArt SAHWR2025-11-10
10603295559436INHANCE INTACTDEPUY (IRELAND)HWR2025-06-13
10603295551768INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-03-07
10603295551805INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
10603295560050INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
G079C5080000040MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2023-10-03
G079C5080000160MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2023-10-03
00887868561368VersaNail®Biomet Orthopedics, LLCHWR2023-09-07
09348215083069Dual Mobility Sleeve DriverSIGNATURE ORTHOPAEDICS PTY LTDHWR2023-01-27
G079C5070000030Golden Isles Pedicle Screw SystemIntelivation, LLCHWR2022-09-23
10603295547631INHANCEDEPUY (IRELAND)HWR2022-05-16
10603295538912INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295538943INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295539339INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295539353INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295539391INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295539476INHANCEDEPUY (IRELAND)HWR2021-08-30
10705034371856N/ADEPUY SPINE, LLCHWR2019-02-01
10603295094869NADEPUY ORTHOPAEDICS, INC.HWR2018-09-24
10603295142720AGILITYDEPUY ORTHOPAEDICS, INC.HWR2018-09-24
10603295171904S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295171911S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295171928S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295171935S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295171942S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295171959S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295171966S-ROMDEPUY (IRELAND)HWR2018-09-24
10603295215868P.F.C.DEPUY (IRELAND)HWR2018-09-24
10603295240730CHARNLEYDEPUY INTERNATIONAL LTDHWR2018-09-24