FDA.reportPublic FDA data

Sochi

Primary DI
00843210167992
Brand
Sochi
Company
Altus Spine, LLC
Model
A16-23-0000
Device description
Rod to Rod Connector, Set Screw
Published
2024-10-03
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
KWPAppliance, Fixation, Spinal Interlaminal
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210887000Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC2021-08-20NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843210167992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843210167992008432101679928432101679920843210167992

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone set screwA small, threaded, implantable, non-bioabsorbable disc intended to be threaded into the proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
610-355-4156QARA@Altus-Spine.com

Regulatory Flags#

DUNS number
078331322
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843210180731Brickyard Stand-Alone ALIF1030-04132024-08-29
00843210176611Indy Standalone1030-04132024-07-24
00843210133478Imola-Silverstone600-31092018-10-06
00843210134161Imola-Silverstone790-00022018-10-06
00843210176567Sochi300-09012025-03-13
00843210167381SochiA16-30-25352024-10-03
00843210167398SochiA16-30-31412024-10-03
00843210167404SochiA16-30-38482024-10-03
B41710010011Monza Cervical Plate System100-10012016-10-28
B41711040121Monza Cervical Plate System110-40122016-10-28
B41711040141Monza Cervical Plate System110-40142016-10-28
B41711040161Monza Cervical Plate System110-40162016-10-28
B41711040181Monza Cervical Plate System110-40182016-10-28
B41711043121Monza Cervical Plate System110-43122016-10-28
B41711043141Monza Cervical Plate System110-43142016-10-28
B41711043161Monza Cervical Plate System110-43162016-10-28
B41711043181Monza Cervical Plate System110-43182016-10-28
B41711140121Fuji Cervical Plate System111-40122017-08-22
B41711140131Fuji Cervical Plate System111-40132017-08-22
B41711140141Fuji Cervical Plate System111-40142017-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-30
00840606193382Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193399Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193405Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193412Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193429Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193436Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193443Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193450Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194044Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194051Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194068Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194075Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194082Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194099Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194105Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194112Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194129Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194136Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194143Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194150Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194167Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194174Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194181Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194198Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194204Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194211Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194228Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194235Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194242Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30