FDA.reportPublic FDA data

PASS LP

Primary DI
03613720205531
Brand
PASS LP
Company
MEDICREA INTERNATIONAL
Model
B32146033R
Device description
PRE-CUT CoCr UNIT ROD Ø 6mm x 330mm - RIGHT
Published
2015-10-23
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
MNHOrthosis, Spondylolisthesis Spinal Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132575000PASS LP SPINAL SYSTEMMedicrea International2013-10-03OSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03613720205531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03613720205531036137202055313613720205531

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
383228632
Device count
1
Lot or batch
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
B06210018530Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018535Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018540Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018545Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018550Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018555Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018560Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018565Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018570Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018575Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018580Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018585Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018590Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038530Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038535Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038540Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038545Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038550Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038555Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038560Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038565Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038570Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038575Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038580Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038585Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210038590Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210048530Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B062100100000JBlack Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-02-14
B06210022070Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-01-13
B06210022075Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-01-13