LCP · 04.120.708S
Synthes GmbH · 3.5 MM TI LCP POSTEROMEDIAL PROX TIBIA PL 8 H/157 MM -STER
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- Labeling does not contain MRI Safety Information
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- true
- Commercial distribution status
- In Commercial Distribution
- Device description
- 3.5 MM TI LCP POSTEROMEDIAL PROX TIBIA PL 8 H/157 MM -STER
- Public device record key
- a34d3f2a-ff99-4337-8361-096d541f4719
- Has serial number
- false
- Public version date
- 2026-05-21
- Is direct marking exempt
- false
- Public version number
- 8
- Labeler duns number
- 486711679
- Is labeled as no nrl
- false
- Is single use
- true
- Is otc
- false
- Version or model number
- 04.120.708S
- Has manufacturing date
- false
- Brand name
- LCP
- Is combination product
- false
- Is kit
- false
- Device count in base package
- 1
- Is pm exempt
- false
- Has lot or batch number
- true
- Catalog number
- 04120708S
- Company name
- Synthes GmbH
- Public version status
- Update
- Has expiration date
- true
- Is hct p
- false
- Publish date
- 2015-09-14
- Sterilization
- Is sterile
- true
- Is sterilization prior use
- true
- Sterilization methods
- Moist Heat or Steam Sterilization
- Identifiers
- ID
- H67904120708S0
- Type
- Secondary
- Issuing agency
- HIBCC
- ID
- 10886982109910
- Type
- Primary
- Issuing agency
- GS1
- Product codes
- Code
- HRS
- Name
- PLATE, FIXATION, BONE
- Harmonized identifiers (openFDA)
- Device name
- Plate, Fixation, Bone
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3030
- Device class
- 2
- Premarket submissions
- Submission number
- K082624
- Supplement number
- 000
- Customer contacts
- Phone
- +1(800)255-2500
- xx@xx.xx
- Gmdn terms
- Code
- 46647
- Name
- Orthopaedic fixation plate, non-bioabsorbable
- Implantable
- true
- Code status
- Active
- Definition
A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.