DEVICE: Taperloc Complete Hip System (00880304907416)

Device Identifier (DI) Information

Taperloc Complete Hip System
SSI003792
In Commercial Distribution
SSI003792
Biomet Orthopedics, LLC
00880304907416
GS1

1
129278169 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
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?
36167 Orthopaedic broach
A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K101086 000
K103755 000
K110400 000
K120030 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
Device Size Text, specify: Size 5
CLOSE

Device Record Status

c97a7abc-4994-42c3-aa2f-88b6ea126c43
May 30, 2025
4
March 27, 2017
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
No Secondary DIs found
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)348-9500
customerservice@zimmerbiomet.com
CLOSE