FDA.reportPublic FDA data

LEVEL ONE CMF

Primary DI
00888118154934
Brand
LEVEL ONE CMF
Company
KLS-Martin L.P.
Model
25-874-15-91
Device description
SCREW, MAXDRIVE, EMERGENCY, TI-6AL-4V
Published
2026-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118154934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118154934008881181549348881181549340888118154934

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbableA small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118150288LEVEL ONE CMF, STERILE50-280-00-712026-10-21
00888118150295LEVEL ONE CMF, STERILE50-280-03-712026-10-21
00888118150301LEVEL ONE CMF, STERILE50-280-05-712026-10-21
00888118150318LEVEL ONE CMF, STERILE50-280-07-712026-10-21
00888118150325LEVEL ONE CMF, STERILE50-280-09-712026-10-21
00888118150332LEVEL ONE CMF, STERILE50-280-11-712026-10-21
00888118150349LEVEL ONE CMF, STERILE50-282-00-712026-10-21
00888118150356LEVEL ONE CMF, STERILE50-282-03-712026-10-21
00888118150363LEVEL ONE CMF, STERILE50-282-05-712026-10-21
00888118150370LEVEL ONE CMF, STERILE50-282-07-712026-10-21
00888118150387LEVEL ONE CMF, STERILE50-282-09-712026-10-21
00888118150394LEVEL ONE CMF, STERILE50-282-11-712026-10-21
00888118150400LEVEL ONE CMF, STERILE50-302-09-712026-10-21
00888118150417LEVEL ONE CMF, STERILE50-302-11-712026-10-21
00888118154910LEVEL ONE CMF25-874-11-612026-10-21
00888118154927LEVEL ONE CMF25-874-11-912026-10-21
00888118154941LEVEL ONE CMF25-874-15-612026-10-21
00888118154958LEVEL ONE CMF, STERILE25-874-11-712026-10-21
00888118154965LEVEL ONE CMF, STERILE25-874-15-712026-10-21
00888118155580UPPER EXTREMITY, IPS60-011-56-09-LP2026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118154910LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118154927LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118154965LEVEL ONE CMF, STERILEKLS-Martin L.P.MQN2026-10-21
10888118154979LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
10888118154986LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118128638LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128645LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128652LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128669LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128676LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128683LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118112682LEVEL ONE CMFKLS-Martin L.P.MQN2018-01-26
00888118113399DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113405DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113412DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113429DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113436DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113443DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118108685LEVEL ONE CMFKLS-Martin L.P.MQN2017-08-17
00888118107800LEVEL ONE CMFKLS-Martin L.P.MQN2017-03-31
00888118107817LEVEL ONE CMFKLS-Martin L.P.MQN2017-03-31
00888118104007DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104014DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104021DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104038DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104045DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104052DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118105431DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118105554DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118105561DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16