FDA.reportPublic FDA data

PASS OCT

Primary DI
03613720265016
Brand
PASS OCT
Company
MEDICREA INTERNATIONAL
Model
B17153504
Device description
Ø3.5 MM x 40MM ROD
Published
2017-01-27
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
NKGOrthosis, Cervical Pedicle Screw Spinal Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161149000PASS OCT Spinal SystemMedicrea International SA2016-07-11NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03613720265016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03613720265016036137202650163613720265016

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of 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. 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
DM exempt
true
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
00840606193382Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193399Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193405Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193412Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193429Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193436Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193443Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193450Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194044Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194051Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194068Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194075Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194082Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194099Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194105Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194112Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194129Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194136Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194143Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194150Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194167Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194174Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194181Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194198Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194204Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194211Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194228Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194235Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194242Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194259Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30