FDA.reportPublic FDA data

PERLA ® TL MIS

Primary DI
07640450867827
Brand
PERLA ® TL MIS
Company
SpineArt SA
Model
MPF-IN 31 00-N
Catalog number
MPF-IN 31 00-N
Device description
XTAB HEAD CLIPPER SHAFT
Published
2021-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203506000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203506000PERLA® TL posterior osteosynthesis systemSpineart2021-01-15NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640450867827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640450867827076404508678277640450867827

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483016148
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
07640139343185BAGUERA C INSTRUMENTATIONCDP-IN 30 01-N2026-08-27
07640221370884TRYPTIK® TiTRY-BX 40 01-N2026-08-27
07640178972452ROMEO posterior osteosynthesis systemNAV-IN 01 00-NNAV-IN 01 00-N2019-01-31
07640221370891BAGUERA® CBAG-CT 13 05-S2026-08-21
07640221370907BAGUERA® CBAG-CT 13 06-S2026-08-21
07640221370914BAGUERA® CBAG-CT 13 07-S2026-08-21
07640221370921BAGUERA® CBAG-CT 14 05-S2026-08-21
07640221370938BAGUERA® CBAG-CT 14 06-S2026-08-21
07640221370945BAGUERA® CBAG-CT 14 07-S2026-08-21
07640221370952BAGUERA® CBAG-CT 16 05-S2026-08-21
07640221370969BAGUERA® CBAG-CT 16 06-S2026-08-21
07640221370976BAGUERA® CBAG-CT 16 07-S2026-08-21
07640139343079BAGUERA® CCDP-IN 00 03-N2026-08-19
07640221370525BAGUERA® CCDP-IN 00 07-N2026-08-19
07640221370532BAGUERA® CCDP-IN 00 06-N2026-08-19
07640221370549BAGUERA® CCDP-IN 61 00-N2026-08-19
07640221370556BAGUERA® CCDP-IN 60 01-N2026-08-19
07640221370563BAGUERA® CCDP-IN SM 05-N2026-08-19
07640221370570BAGUERA® CCDP-IN ME 05-N2026-08-19
07640221370587BAGUERA® CCDP-IN LA 05-N2026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157113384ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113391ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113407ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113414ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113421ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113438ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113445ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113452ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113469ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113476ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113483ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113490ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113506ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113513ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113520ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113537ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113544ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113551ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113568ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113575ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113582ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113599ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113605ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113612ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113629ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113636ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113643ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113650ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113667ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113674ZAVATION SCREWZavation LLCNKB2026-09-04