FDA.reportPublic FDA data

mambo™ modular cervical plate system

Primary DI
04052536008261
Brand
mambo™ modular cervical plate system
Company
Ulrich GmbH & Co. KG
Model
CS 1824-29
Catalog number
CS 1824-29
Device description
mambo plate L blue, 4-hole, length 29 mm
Published
2016-07-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090861000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090861000MAMBO, MODEL CS 18XX-XXUlrich GmbH & Co. KG2010-05-21KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052536008261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052536008261040525360082614052536008261

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4907319654152safety@ulrichmedical.com
+4973196540safety@ulrichmedical.com

Regulatory Flags#

DUNS number
315494757
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
04052536052912uCentumUL 8525-232025-08-04
04052536078264uCentumCS 71382025-08-01
04052536078271uCentumCS 71402025-08-01
04052536078295uCentumCS 71442025-08-01
04052536176823N/ACS 3993-900CS 3993-9002019-05-21
04052536164417N/ACS 3995-003-000CS 3995-003-0002018-02-14
04052536164530N/ACS 3995-002-000CS 3995-002-0002018-02-14
04052536164547N/ACS 3995-001-000CS 3995-001-0002018-02-14
04052536164554N/ACS 3995-001-001CS 3995-001-0012018-02-14
04052536164615N/ACS 3994-001-004CS 3994-001-0042018-02-14
04052536164622N/ACS 3995-001-002CS 3995-001-0022018-02-14
04052536085620N/ACS 3938-03CS 3938-032016-09-22
04052536085705N/ACS 3944-02CS 3944-022016-09-22
04052536085781N/ACS 3952-01CS 3952-012018-02-14
04052536085798N/ACS 3952-02CS 3952-022018-02-14
04052536085811N/ACS 3954-01CS 3954-012018-02-14
04052536085866N/ACS 3961CS 39612016-09-22
04052536161980N/ACS 3939-01CS 3939-012016-09-22
04052536162024N/ACS 3944-03CS 3944-032016-09-22
04052536162031N/ACS 3945-01CS 3945-012016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.KWQ2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.KWQ2026-06-05
00840283407949VyPlate™VY SPINE LLCKWQ2026-06-05
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