DEVICE: PRECICE® Intramedullary Limb Lengthening System (00856719002053)

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Device Record History
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Device Identifier (DI) Information
PRECICE® Intramedullary Limb Lengthening System
P003
In Commercial Distribution
EAD-P1-012
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
00856719002053
GS1

1
837845234 *Terms of Use
ERC1, PRECICE, Shipping Pkg UK
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Device Characteristics
MR Unsafe
No
No
No
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?
43538 Distraction implant adjustment remote control
A portable, hand-held, electrically-powered device intended to noninvasively and remotely adjust the length of a previously-implanted extramedullary distraction plate and/or intramedullary distraction nail to correct long bone fractures and limb length discrepancies, and/or with spinal distraction rod to correct spinal deformities; it may be used intraoperatively to test the functionality of the implantable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HSB Rod, Fixation, Intramedullary And Accessories
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 60 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
282fe2ce-5d10-4b0e-9e46-6b97ae3a4ffa
May 28, 2025
5
March 10, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
866-456-2871
info@globusmedical.com
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