FDA.reportPublic FDA data

Hinged Laminoplasty

Primary DI
00190837104351
Brand
Hinged Laminoplasty
Company
Life Spine, Inc.
Model
174-1906
Catalog number
174-1906
Device description
9mm X 6mm Laminoplasty Spacer
Published
2019-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K191927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191927000Hinged Laminoplasty SystemLife Spine, Inc.2019-09-20NQW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190837104351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190837104351001908371043511908371043510190837104351

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

Regulatory Flags#

DUNS number
183641617
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190837085728ProLift Lateral149-4002149-40022019-11-19
00190837030919Pro Lift Instruments114-204-2114-204-22019-11-07
00190837030926Pro Lift Instruments114-204-3114-204-32019-11-07
00190837030957Pro Lift Instruments151-219151-2192019-11-07
00190837030964Pro Lift Instruments112-222112-2222019-11-07
00190837030988Pro Lift Instruments112-351112-3512019-11-07
00190837030995Pro Lift Instruments129-1006129-10062019-11-07
00190837031008Pro Lift Instruments129-1007129-10072019-11-07
00190837031015Pro Lift Instruments129-1008129-10082019-11-07
00190837031022Pro Lift Instruments129-1009129-10092019-11-07
00190837031039Pro Lift Instruments129-1010129-10102019-11-07
00190837031046Pro Lift Instruments129-1011129-10112019-11-07
00190837031053Pro Lift Instruments129-1012129-10122019-11-07
00190837031060Pro Lift Instruments129-1013129-10132019-11-07
00190837031077Pro Lift Instruments151-262151-2622019-11-07
00190837031084Pro Lift Instruments151-265151-2652019-11-07
00190837031091Pro Lift Instruments151-268151-2682019-11-07
00190837031107Pro Lift Instruments151-271151-2712019-11-07
00190837031121Pro Lift Instruments151-277151-2772019-11-07
00190837031138Pro Lift Instruments151-280151-2802019-11-07

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