DEVICE: NA (10705034741291)

Device Identifier (DI) Information

NA
04.616.225
In Commercial Distribution
04616225
Synthes GmbH
10705034741291
GS1

1
486711679 *Terms of Use
5.5MM TI ROD 125MM
CLOSE

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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61325 Bone-screw internal spinal fixation system, non-sterile
An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MNI ORTHOSIS, SPINAL PEDICLE FIXATION
MNH Orthosis, spondylolisthesis spinal fixation
NKB Orthosis, spinal pedicle fixation, for degenerative disc disease
KWQ APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092929 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

5e574a28-9945-4735-bb5e-95777bd62a6c
April 26, 2022
4
September 14, 2015
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
HIBCC H981046162250
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
CLOSE