FDA.reportPublic FDA data

NA

Primary DI
34546540259043
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
62-20020
Catalog number
62-20020
Device description
SELF-DRILLING PINS, AUTO PILOT
Published
2015-07-07
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
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQNExternal Mandibular Fixator And/Or DistractorDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960297000MANDIBULAR BONE DISTRACTOR IIHowmedica Corp.1996-08-06MQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34546540259043PrimaryGS10
04546540259042Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654025904334546540259043
04546540259042045465402590424546540259042

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length6Centimeter
Length10Millimeter
Length60Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
2
DM exempt
true
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
04546540717443ORTHOMAP6003-655-0006003-655-0002017-12-12
07613154272105HYDROSET3970033970032015-09-24
07613154272112HYDROSET3970053970052015-09-24
07613154272129HYDROSET3970103970102015-09-24
07613154272136HYDROSET3970153970152015-09-24
07613154274994HYDROSET79-4390379-439032015-09-24
07613154275007HYDROSET79-4390579-439052015-09-24
07613154275014HYDROSET79-4391079-439102015-09-24
07613154275021HYDROSET79-4391579-439152015-09-24
07613154804764HYDROSET3970233970232015-09-24
07613154804771HYDROSET3970213970212015-09-24
07613154804788HYDROSET7070017070012015-09-24
07613154888153HYDROSET3970273970272015-09-24
07613252510673CRANIALMAP6000-655-1006000-655-1002016-08-24
07613252510703CRANIALMAP6000-655-1506000-655-1502016-08-24
07613252510710CRANIALMAP6000-655-3006000-655-3002016-08-24
07613252510802CRANIALMAP6001-655-1506001-655-1502016-08-24
07613252510819CRANIALMAP6001-655-1006001-655-1002016-08-24
07613252510857CRANIALMAP6001-655-3006001-655-3002016-08-24
07613327004274CRANIALMAP6001-655-0006001-655-0002016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118108685LEVEL ONE CMFKLS-Martin L.P.MQN2017-08-17
00888118006189LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118006202LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118006226LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118007261LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118007278LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118032812LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118037480LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118037503LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118037510LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118039439LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118039446LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044457LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044471LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044495LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044518LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044532LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044556LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044631LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044655LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044679LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045010LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045034LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045058LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045072LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045096LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045119LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045133LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045195LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045485LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24