FDA.reportPublic FDA data

PASS LP

Primary DI
03613720284802
Brand
PASS LP
Company
MEDICREA INTERNATIONAL
Model
B36114545
Catalog number
B36114545
Device description
CANNULATED REDUCTION SCREW Ø4.5 mm X 45 mm
Published
2020-03-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190376000PASS LP Spinal SystemMedicrea International SA2019-05-02NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03613720284802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03613720284802036137202848023613720284802

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
383228632
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03613720249832PASS TLA220302002017-01-31
03613720286875UNiD OCTB33243600-01B33243600-012021-08-19
03613720286882UNiD OCTB33243500-01B33243500-012021-08-19
03613720286899UNiD OCTB33143600-01B33143600-012021-08-19
03613720286905UNiD OCTB33143500-01B33143500-012021-08-19
03613720286936UNiD RODB33136012-01B33136012-012021-08-19
03613720286943UNiD RODB33236012-01B33236012-012021-08-19
03613720268451UNiD RODB33125512-01B33125512-012017-06-12
03613720268468UNiD RODB33125512-02B33125512-022017-06-12
03613720268628UNiD RODB33225512-01B33225512-012017-06-12
03613720268635UNiD RODB33225512-02B33225512-022017-06-12
03613720268963UNiD RODB33126012-01B33126012-012017-08-28
03613720268970UNiD RODB33126012-02B33126012-022017-08-28
03613720269137UNiD RODB33226012-01B33226012-012017-08-28
03613720269144UNiD RODB33226012-02B33226012-022017-08-28
03613720269304UNiD OCTB33123500-01B33123500-012017-09-12
03613720269311UNiD OCTB33123500-02B33123500-022017-09-12
03613720269397UNiD OCTB33223500-01B33223500-012017-09-12
03613720269403UNiD OCTB33223500-02B33223500-022017-09-12
03613720286585UNiD MISB33155522-01B33155522-012021-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422800RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422817RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422824RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422831RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422848RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422855RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422862RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422879RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422886RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05