FDA.reportPublic FDA data

Spinal Instrument

Primary DI
03700780639168
Brand
Spinal Instrument
Company
CLARIANCE
Model
99762003
Catalog number
99762003
Device description
SLAP HAMMER (L)
Published
2022-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202032000Idys LLIF 3DTiClariance, Sas2021-04-01OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700780639168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700780639168037007806391683700780639168

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 773 868 7041s.chambat@clariance-spine.us

Regulatory Flags#

DUNS number
296568400
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700780634583Erisma®-LP18710039187100392026-05-28
03700780643554Erisma®-LP15742006157420062026-02-26
03700780600120Idys™- LIF04522008-S04522008-S2015-10-22
03700780600137Idys™- LIF04522009-S04522009-S2015-10-22
03700780600168Idys™- LIF04522012-S04522012-S2015-10-22
03700780600175Idys™- LIF04522013-S04522013-S2015-10-22
03700780600182Idys™- LIF04522508-S04522508-S2015-10-22
03700780600199Idys™- LIF04522509-S04522509-S2015-10-22
03700780600212Idys™- LIF04522011-S04522011-S2015-10-22
03700780600229Idys™- LIF04522512-S04522512-S2015-10-22
03700780600243Idys™- LIF04522514-S04522514-S2015-10-22
03700780600267Idys™- LIF04522809-S04522809-S2015-10-22
03700780600274Idys™- LIF04522810-S04522810-S2015-10-22
03700780600281Idys™- LIF04522811-S04522811-S2015-10-22
03700780600298Idys™- LIF04522812-S04522812-S2015-10-22
03700780600311Idys™- LIF04522814-S04522814-S2015-10-23
03700780600335Idys™- LIF04523209-S04523209-S2015-10-23
03700780600342Idys™- LIF04523210-S04523210-S2015-10-23
03700780600359Idys™- LIF04523211-S04523211-S2015-10-23
03700780600366Idys™- LIF04523212-S04523212-S2015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157074050ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074067ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074074ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074081ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074098ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074104ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074111ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074128ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074135ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074142ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074159ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074166ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074173ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074180ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074197ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074203ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074210ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074227ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074234ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074241ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074258ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074265ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074272ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074289ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074296ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074302ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074319ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074326ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074333ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074340ZAVATION SCREWZavation LLCOVD2026-05-29