FDA.reportPublic FDA data

LIBRA

Primary DI
00889024355668
Brand
LIBRA
Company
SYNVASIVE TECHNOLOGY, INC.
Model
20-8012-010-04
Catalog number
20-8012-010-04
Published
2016-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00889024355668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024355668008890243556688890243556680889024355668

GMDN Terms#

Term, Definition table
TermDefinition
Knee arthroplasty force sensor balance kitA collection of non-sterile devices intended for use with a knee arthroplasty force sensor to measure forces acting across the joint to facilitate assessment of bone resection lines and size of prosthesis components to be implanted. It is intended to help achieve correct femoral rotation, flexion stability, proper patella tracking, and/or medial-lateral ligament balance. It typically consists of femoral components, tibial spacers, positioning guides, fixation screws, and an adjustment wrench. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
618258974
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
00889024430273NEO CLASSIC™20-8012-010-4720-8012-010-472016-07-07
00846795000234Stablecut®11-22102017-12-08
00846795000302Stablecut®11-22172017-12-08
00846795000357Stablecut®11-22222017-12-08
00846795000388Stablecut®11-22352017-12-08
00846795000449Stablecut®11-22382017-12-08
00846795000968Stablecut®11-26182017-04-28
00846795001156Stablecut®11-27392017-04-28
00846795002207Stablecut®11-35362017-04-28
00846795002337Stablecut®11-35812017-04-28
00846795002344Stablecut®11-35822017-04-28
00846795002351Stablecut®11-35832017-04-28
00846795002368Stablecut®11-35842017-04-28
00846795002375Stablecut®11-35852017-04-28
00846795002382Stablecut®11-35862017-04-28
00846795002450Stablecut®11-36042017-04-28
00846795002511Stablecut®11-36562017-04-28
00846795002580Stablecut®11-36742017-04-28
00846795002641Stablecut®11-37322017-04-28
00846795002672Stablecut®11-37392017-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010196Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449010288Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035243Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035250Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035267Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00810094692698Modular Frog EyesTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692704Distal Femoral Cut Block ConnectorTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692933Magnet Spacer, 5mmTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
04052536123728mamboUlrich GmbH & Co. KGLXH2026-06-09
08809945870578BENCOXCorentec Co., LtdLXH2026-06-09
04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162079neon3Ulrich GmbH & Co. KGLXH2026-06-08
00198506091445ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-05
00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03