DEVICE: PRIMA Proximal Femur Locking Plate System (B56211113361800S10)
Device Identifier (DI) Information
PRIMA Proximal Femur Locking Plate System
11-113-361800S-1
In Commercial Distribution
Wishbone Medical, Inc.
11-113-361800S-1
In Commercial Distribution
Wishbone Medical, Inc.
3.5mm Proximal Femur Plate, 130°, 6 hole, 18° flare, no offset, SS
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46649 | Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial |
A collection of small sheets of firm material and bone screws intended to be implanted onto fractured bone fragments to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. The components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre); it does not include an antimicrobial agent(s). Tools for implantation may be included. The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HRS | Plate, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K230527 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
19bb8f87-3328-4a33-b2aa-7bbf46e1e972
February 19, 2024
2
April 12, 2023
February 19, 2024
2
April 12, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(574) 306-4006
WeCare@WishBoneMedical.com
WeCare@WishBoneMedical.com