FDA.reportPublic FDA data

MOUNTAINEER

Primary DI
10705034159119
Brand
MOUNTAINEER
Company
Medos International Sàrl
Model
188370008
Catalog number
188370008
Device description
MOUNTAINEER LAMINOPLASTY SYSTEM SCREW 2.30mm x 8mm
Published
2015-09-24
Public version status
Update
Distribution status
Not 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
NQWORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQWOrthosis, Spine, Plate, Laminoplasty, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091994000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091994000MOUNTAINEER LAMINOPLASTY SYSTEMDepuy Spine, Inc.2010-01-07NQW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034159119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503415911910705034159119

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
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
03662663146524Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146531Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146548Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146555Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146562Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146579Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146586Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146593Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146609Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146616Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146623Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146234Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146241Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146258Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146265Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146272Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146289Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146296Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146302Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146319Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146326Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146333Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146340Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146357Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146364Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146371Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146388Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146395Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146401Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146418Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15