FDA.reportPublic FDA data

BULLET-TIP PEEK IBF SYSTEM

Primary DI
00191083026466
Brand
BULLET-TIP PEEK IBF SYSTEM
Company
Xtant Medical Holdings, Inc.
Model
724-525
Catalog number
724-525
Device description
BULLET TIP HUDSON CON INSERTER
Published
2020-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191083026466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083026466001910830264661910830264660191083026466

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386)418-8888labeling@rtix.com

Regulatory Flags#

DUNS number
081224143
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311224425Cortera Spinal Fixation System150211-553002026-05-18
00840311224432Cortera Spinal Fixation System150211-554002026-05-18
00840311224449Cortera Spinal Fixation System150211-555002026-05-18
00840311224456Cortera Spinal Fixation System150211-556002026-05-18
00840311224463Cortera Spinal Fixation System150211-603002026-05-18
00840311224470Cortera Spinal Fixation System150211-604002026-05-18
00840311224487Cortera Spinal Fixation System150211-605002026-05-18
00840311224494Cortera Spinal Fixation System150211-606002026-05-18
00840311227181Cortera Spinal Fixation System150220-553002026-05-18
00840311227198Cortera Spinal Fixation System150220-554002026-05-18
00840311227204Cortera Spinal Fixation System150220-555002026-05-18
00840311227211Cortera Spinal Fixation System150220-556002026-05-18
00840311227228Cortera Spinal Fixation System150220-603002026-05-18
00840311227235Cortera Spinal Fixation System150220-604002026-05-18
00840311227242Cortera Spinal Fixation System150220-605002026-05-18
00840311227259Cortera Spinal Fixation System150220-606002026-05-18
00840311212767Fortilink-C IBF System65-C-1012-10-6L65-C-1012-10-6L2026-04-30
00840311212774Fortilink-C IBF System65-C-1012-11-6L65-C-1012-11-6L2026-04-30
00840311212798Fortilink-C IBF System65-C-1012-6-6L65-C-1012-6-6L2026-04-30
00840311212804Fortilink-C IBF System65-C-1012-7-6L65-C-1012-7-6L2026-04-30

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