FDA.reportPublic FDA data

ACTIV L

Primary DI
04046963143893
Brand
ACTIV L
Company
Aesculap AG
Model
SW977K
Catalog number
SW977K
Device description
ACTIV L INF.PLATE S1 SIZE S 5°/KEEL
Published
2022-01-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJOProsthesis, intervertebral disc

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJOProsthesis, Intervertebral DiscUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963143893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963143893040469631438934046963143893

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar total intervertebral disc prosthesisAn implantable device designed to replace a dysfunctional intervertebral disc in the lumbar spine. It most commonly has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below and may have a compressible core component between. It may facilitate some degree of motion and is typically made of metal and/or synthetic polymer materials. This is the complete prosthesis assembly, not individual components.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653434022AESCULAPFT944TFT944T2015-09-24
04046963417468AESCULAPFT942TFT942T2015-09-24
04038653042586AESCULAPET251RET251R2016-09-23
04046964227547AESCULAPGF058BGF058B2016-09-23
04038653148998AESCULAPDO706RDO706R2020-04-21
04038653105878AESCULAPLS059RLS059R2020-04-21
04038653106080AESCULAPLS099RLS099R2020-04-21
04038653034666AESCULAPDE419RDE419R2020-06-17
04038653034697AESCULAPDE422RDE422R2020-06-17
04038653105977AESCULAPLS084RLS084R2022-07-29
04038653199020AESCULAPXG105RXG105R2021-10-15
04038653199006AESCULAPXG103RXG103R2020-08-24
04038653199013AESCULAPXG104RXG104R2020-08-24
04038653460533AESCULAPXG106RXG106R2020-08-24
04046963000431AESCULAPXG107RXG107R2020-08-24
04046963000448AESCULAPXG108RXG108R2020-08-24
04046963611538AESCULAPXG126RXG126R2020-08-24
04038653109999AESCULAPND118RND118R2020-05-08
04038653110018AESCULAPND121RND121R2020-05-08
04038653110056AESCULAPND125RND125R2020-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221370891BAGUERA® CSpineArt SAMJO2026-08-21
07640221370907BAGUERA® CSpineArt SAMJO2026-08-21
07640221370914BAGUERA® CSpineArt SAMJO2026-08-21
07640221370921BAGUERA® CSpineArt SAMJO2026-08-21
07640221370938BAGUERA® CSpineArt SAMJO2026-08-21
07640221370945BAGUERA® CSpineArt SAMJO2026-08-21
07640221370952BAGUERA® CSpineArt SAMJO2026-08-21
07640221370969BAGUERA® CSpineArt SAMJO2026-08-21
07640221370976BAGUERA® CSpineArt SAMJO2026-08-21
M670107731500Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107731560Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107731600Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107731660Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107732500Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107732560Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107732600Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107732660Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107733500Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107733560Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107733600Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107733660Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
03662663082037ActivLHighridge Medical, LLCMJO2026-02-03
03662663082044ActivLHighridge Medical, LLCMJO2026-02-03
03662663082051ActivLHighridge Medical, LLCMJO2026-02-03
03662663082068ActivLHighridge Medical, LLCMJO2026-02-03
03662663082075ActivLHighridge Medical, LLCMJO2026-02-03
03662663082082ActivLHighridge Medical, LLCMJO2026-02-03
03662663082099ActivLHighridge Medical, LLCMJO2026-02-03
03662663082105ActivLHighridge Medical, LLCMJO2026-02-03
03662663082112ActivLHighridge Medical, LLCMJO2026-02-03