FDA.report

Specials

Primary DI
10889981159979
Brand
Specials
Company
SEASPINE ORTHOPEDICS CORPORATION
Model
SR-0271-2
Catalog number
SR-0271-2
Device description
Offset Osteotome 3/8 Inch
Published
2020-09-24
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

Related Records

Contact Domains

Product Codes

CodeName
GFIOSTEOTOME, MANUAL

Product Code Classifications

CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10889981159979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088998115997910889981159979

GMDN Terms

TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(760)727-8399custsvcspine@seaspine.com

Regulatory Flags

DUNS number
079840876
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 DIBrandModelCatalogPublished
10889981125820Newport Complex MIS64-956564-95652026-03-03
10889981125851Newport Complex MIS64-959064-95902026-03-03
10889981130084Newport Complex MIS64-750564-75052026-03-03
10889981135331Newport Complex MIS64-552564-55252026-03-03
10889981135386Newport Complex MIS64-555564-55552026-03-03
10889981135393Newport Complex MIS64-556064-55602026-03-03
10889981135522Newport Complex MIS64-655064-65502026-03-03
10889981135553Newport Complex MIS64-656564-65652026-03-03
10889981135584Newport Complex MIS64-658564-65852026-03-03
10889981135591Newport Complex MIS64-659064-65902026-03-03
10889981135867Newport Complex MIS64-754564-75452026-03-03
10889981135997Newport Complex MIS64-851064-85102026-03-03
10889981136017Newport Complex MIS64-858564-85852026-03-03
10889981136079Newport Complex MIS64-957564-95752026-03-03
10889981136086Newport Complex MIS64-958564-95852026-03-03
10889981145668NewPort™65-474565-47452026-03-03
10889981145699NewPort™65-476065-47602026-03-03
10889981145750NewPort™65-555065-55502026-03-03
10889981145866NewPort™65-650065-65002026-03-03
10889981145903NewPort™65-653565-65352026-03-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10889981443764SpecialsSeaspine Orthopedics CorporationGFI2026-03-03
D9281051992HF0SINUS INSTRUMENT #2 HF D/EW.H. Holden, Inc.GFI2026-02-19
10889981441340SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441357SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441364SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441371SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
03662663220873Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
03662663220880Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
03662663220897Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
10889981440787SpecialsSeaspine Orthopedics CorporationGFI2026-01-07
03662663156783SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156790SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156806SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156813SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156820SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156837SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
00757770703708Bausch + LombBausch & Lomb IncorporatedGFI2025-12-12
00757770703715Bausch + LombBausch & Lomb IncorporatedGFI2025-12-12
00757770447046Bausch + LombBausch & Lomb IncorporatedGFI2025-12-11
00810207783312Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783329Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783336Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783343Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783350Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783367Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783374Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783381Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783398Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783404Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783411Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24