FDA.reportPublic FDA data

CLUTCH

Primary DI
00840606116756
Brand
CLUTCH
Company
SPINAL ELEMENTS, INC.
Model
86002-014
Device description
14 X 40MM FLARED Z PLATE PC
Published
2018-12-26
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
PEKSpinous process plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEKSpinous Process PlateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606116756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606116756008406061167568406061167560840606116756

GMDN Terms#

Term, Definition table
TermDefinition
Interspinous spinal fixation implantAn implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (760) 607 0121info@spinalelements.com

Regulatory Flags#

DUNS number
610712213
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606158213KARMA75310-0002020-03-03
00840466901196Primus66012-095-0302026-03-27
00840466901202Primus66012-095-0352026-03-27
00840466901219Primus66012-105-0302026-03-27
00840466901226Primus66012-105-0352026-03-27
00840466901233Primus66012-105-0402026-03-27
00840466901240Primus66012-105-0452026-03-27
00840466901257Primus66012-105-0502026-03-27
00840466901264Primus66012-105-0552026-03-27
00840466901271Primus66023-045-0302026-03-27
00840466901288Primus66023-045-0352026-03-27
00840466901295Primus66023-045-0402026-03-27
00840466901301Primus66023-045-0452026-03-27
00840466901318Primus66023-045-0502026-03-27
00840466901325Primus66023-055-0252026-03-27
00840466901332Primus66023-055-0302026-03-27
00840466901349Primus66023-055-0352026-03-27
00840466901356Primus66023-055-0402026-03-27
00840466901363Primus66023-055-0452026-03-27
00840466901370Primus66023-055-0502026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M9431002200000Minuteman Spinal Simplicity, LLCPEK2026-02-23
M9431002210000Minuteman Spinal Simplicity, LLCPEK2026-02-23
M9431002220000Minuteman Spinal Simplicity, LLCPEK2026-02-23
M9431002230000Minuteman Spinal Simplicity, LLCPEK2026-02-23
M9431002240000Minuteman Spinal Simplicity, LLCPEK2026-02-23
10889981146498GeneralSeaspine Orthopedics CorporationPEK2025-12-19
07640185341678ROMEO 2 PAD INSTRUMENTATIONSpineArt SAPEK2025-11-11
B1830712181100KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712181120KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712181140KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712181160KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712200100KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712200120KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712200140KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712200160KeyLift™FLOSPINE LLCPEK2025-02-03
10889981146412NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146436NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146443NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146450NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146467NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146474NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146481NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981096298GeneralSeaspine Orthopedics CorporationPEK2024-06-11
10889981096304GeneralSeaspine Orthopedics CorporationPEK2024-06-11
10889981096311GeneralSeaspine Orthopedics CorporationPEK2024-06-11
00190837137090Aileron TRXLife Spine, Inc.PEK2022-07-11
M9431001040000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13
M9431001000000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13
M9431001010000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13
M9431001020000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13