FDA.reportPublic FDA data

Sonoma Orthopedic Products, Inc

Primary DI
00816988011507
Brand
Sonoma Orthopedic Products, Inc
Company
SONOMA ORTHOPEDIC PRODUCTS, INC.
Model
Sonoma Fibula Rod Right 3.0 x 130mm
Catalog number
FIB30130R
Published
2015-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816988011507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816988011507008169880115078169880115070816988011507

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
884789251
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816988010197Sonoma Orthopedic Products, Inc2.7mm Bone Screw Caddy/ CoverIN01182015-09-17
00816988010739Sonoma Orthopedic Products, IncSONOMA WRX Inner Sterilization CaseIN01032015-09-17
00816988010746Sonoma Orthopedic Products, IncScrew Caddy With Peg CaddyIN01042015-09-17
00816988012030Sonoma Orthopedic Products, IncInstrument CaseIN68002015-08-19
00816988012047Sonoma Orthopedic Products, IncInstrument Case Inner TrayIN68012015-08-19
00816988012054Sonoma Orthopedic Products, IncInstrument Case LidIN68022015-08-19
00816988012368Sonoma Orthopedic Products, Inc.Fib First Gen Bottom Insert TrayIN68032017-07-07
00816988012467Sonoma Orthopedic Products, Inc.Fibulock Instrument Gase Gen2IN68052016-02-04
00816988012474Sonoma Orthopedic Products, Inc.Fibulock Instrument Case Base Gen2IN6805-012016-02-04
00816988012481Sonoma Orthopedic Products, Inc.Fibulock Instrument Case Lid Gen2IN6805-022016-02-04
00816988012498Sonoma Orthopedic Products, Inc.Fibulock Instrument Case Insert Tray Gen2IN6805-032016-02-04
00816988012504Sonoma Orthopedic Products, Inc.Fibulock Instrument Case Screw Caddy and Lid Gen2IN6805-042016-02-04
00816988013068Sonoma Orthopedic Products, Inc.Jones Bolt Instrument Tray BaseIN7800-012017-04-04
00816988013075Sonoma Orthopedic Products, Inc.Jones Bolt Instrument Tray LidIN7800-022017-04-04
00816988013174Sonoma Orthopedic Products, Inc.WRx Tray with Irremovable Innermost TrayIN01492017-09-20
00816988011446Sonoma Orthopedic Products, IncCRx DISPOSABLE INTRUMENTS PACKAGEST0101_A2015-09-08
00816988010593Sonoma Orthopedic Products, IncWRx OutriggerIN01502015-09-17
00816988010609Sonoma Orthopedic Products, Inc5mm Hub Attachment Tube "Outrigger"IN01512015-09-17
00816988010616Sonoma Orthopedic Products, Inc5mm Hub Attachment Screw "Outrigger"IN01522015-09-17
00816988010630Sonoma Orthopedic Products, Inc6mm Hub Attachment Screw "Outrigger"IN01622015-09-17

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00887868150371Affixus®Zimmer, Inc.HSB2026-03-19
00887868150388Affixus®Zimmer, Inc.HSB2026-03-19
00887868150395Affixus®Zimmer, Inc.HSB2026-03-19
00887868150401Affixus®Zimmer, Inc.HSB2026-03-19
00887868150555Affixus®Zimmer, Inc.HSB2026-03-19
00887868150562Affixus®Zimmer, Inc.HSB2026-03-19
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00887868150913Affixus®Zimmer, Inc.HSB2026-03-19
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00889024700253Affixus®Zimmer, Inc.HSB2026-03-19
00889024700260Affixus®Zimmer, Inc.HSB2026-03-19
00889024700277Affixus®Zimmer, Inc.HSB2026-03-19
00889024700284Affixus®Zimmer, Inc.HSB2026-03-19
00889024700291Affixus®Zimmer, Inc.HSB2026-03-19
00888867463363Arthrex®ARTHREX, INC.HSB2026-03-16
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