FDA.reportPublic FDA data

KMEDIC

Primary DI
54026704921954
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN015249
Catalog number
KM55496
Device description
LUMBAR LAMINA SPREADER #2 4 1/4"
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54026704921954Direct MarkingGS10
14026704921956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5402670492195454026704921954
1402670492195614026704921956

GMDN Terms#

Term, Definition table
TermDefinition
Bone distraction forcepsA hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length13.3Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089664ELMED INCORPORATEDELMED INCORPORATEDHAO2026-03-17
00810220800010Adler Instrument CompanyAdler, Inc.HAO2026-03-17
00810220800034Adler Instrument CompanyAdler, Inc.HAO2026-03-17
04058749078770NAFehling Instruments GmbH & Co. KGHAO2026-03-05
04058749082357NAFehling Instruments GmbH & Co. KGHAO2026-03-05
04058749123500NAFehling Instruments GmbH & Co. KGHAO2026-03-05
00816589021608Mini-Bolt Accessory KitMONTERIS MEDICAL INCHAO2026-02-23
00810123209835Adler Instrument CompanyAdler, Inc.HAO2026-02-10
04058749068443NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749068481NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749076110NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749076349NAFehling Instruments GmbH & Co. KGHAO2026-01-28
00810123209750Adler Instrument CompanyAdler, Inc.HAO2026-01-02
00810123209767Adler Instrument CompanyAdler, Inc.HAO2026-01-02
00873263009321Visualase Anchor Bolt ToolsFHC, INC.HAO2025-12-12
00873263009345Visualase Anchor Bolt DriverFHC, INC.HAO2025-12-12
00873263009352Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009369Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009376Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009383Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009390Visualase Sterilization & Storage TrayFHC, INC.HAO2025-12-12
00873263009406Visualase Anchor Bolt Removal ToolFHC, INC.HAO2025-12-12
04058749001846NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749002010NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749068467NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749069969NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749069976NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749076059NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082517NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082562NAFehling Instruments GmbH & Co. KGHAO2025-12-08