MANZA HEADS 103-31-031

GUDID 00841176101777

MANZA BIOLOX DELTA HEAD OFFSET, 32 M

STINSON ORTHOPEDICS INC.

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 00841176101777
• NIH Device Record Key: 38522694-4425-4569-ac11-4fe02e48ea16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MANZA HEADS
• Version Model Number: 103-31-031
• Catalog Number: 103-31-031
• Company DUNS: 080460688
• Company Name: STINSON ORTHOPEDICS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841176101777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-26

On-Brand Devices [MANZA HEADS]

• 00841176103207: MANZA UNIPOLAR HEAD, 60MM
• 00841176103191: MANZA UNIPOLAR HEAD, 59MM
• 00841176103184: MANZA UNIPOLAR HEAD, 58MM
• 00841176103177: MANZA UNIPOLAR HEAD, 57MM
• 00841176103160: MANZA UNIPOLAR HEAD, 56MM
• 00841176103153: MANZA UNIPOLAR HEAD, 55MM
• 00841176103146: MANZA UNIPOLAR HEAD, 54MM
• 00841176103139: MANZA UNIPOLAR HEAD, 53MM
• 00841176103122: MANZA UNIPOLAR HEAD, 52MM
• 00841176103115: MANZA UNIPOLAR HEAD, 51MM
• 00841176103108: MANZA UNIPOLAR HEAD, 50MM
• 00841176103092: MANZA UNIPOLAR HEAD, 49MM
• 00841176103085: MANZA UNIPOLAR HEAD, 48MM
• 00841176103078: MANZA UNIPOLAR HEAD, 47MM
• 00841176103061: MANZA UNIPOLAR HEAD, 46MM
• 00841176103054: MANZA UNIPOLAR HEAD, 45MM
• 00841176103047: MANZA UNIPOLAR HEAD, 44MM
• 00841176103030: MANZA UNIPOLAR HEAD, 43MM
• 00841176103023: MANZA UNIPOLAR HEAD, 42MM
• 00841176103016: MANZA UNIPOLAR HEAD, 41MM
• 00841176103009: MANZA UNIPOLAR HEAD, 40MM
• 00841176101302: MANZA COCR HEAD, 40, XL OFFSET
• 00841176101296: MANZA COCR HEAD, 40, L OFFSET
• 00841176101289: MANZA COCR HEAD, 40, M OFFSET
• 00841176101272: MANZA COCR HEAD, 40, S OFFSET
• 00841176101265: MANZA COCR HEAD, 36, XL OFFSET
• 00841176101258: MANZA COCR HEAD, 36, L OFFSET
• 00841176101241: MANZA COCR HEAD, 36, M OFFSET
• 00841176101234: MANZA COCR HEAD, 36, S OFFSET
• 00841176101227: MANZA COCR HEAD, 32, XL OFFSET
• 00841176101210: MANZA COCR HEAD, 32, L OFFSET
• 00841176101203: MANZA COCR HEAD, 32, M OFFSET
• 00841176101197: MANZA COCR HEAD, 32, S OFFSET
• 00841176101180: MANZA COCR HEAD, 28, L OFFSET
• 00841176101173: MANZA COCR HEAD, 28, M OFFSET
• 00841176101166: MANZA COCR HEAD, 28, S OFFSET
• 00841176103245: MANZA TAPER SLEEVE OFFSET, +8MM
• 00841176103238: MANZA TAPER SLEEVE OFFSET, +4MM
• 00841176103221: MANZA TAPER SLEEVE OFFSET, 0MM
• 00841176103214: MANZA TAPER SLEEVE OFFSET, -4MM
• 00841176101876: MANZA BIOLOX DELTA HEAD OFFSET, 40 XL
• 00841176101869: MANZA BIOLOX DELTA HEAD OFFSET, 40 L
• 00841176101852: MANZA BIOLOX DELTA HEAD OFFSET, 40 M
• 00841176101845: MANZA BIOLOX DELTA HEAD OFFSET, 40 S
• 00841176101838: MANZA BIOLOX DELTA HEAD OFFSET, 36 XL
• 00841176101821: MANZA BIOLOX DELTA HEAD OFFSET, 36 L
• 00841176101814: MANZA BIOLOX DELTA HEAD OFFSET, 36 M
• 00841176101807: MANZA BIOLOX DELTA HEAD OFFSET, 36 S
• 00841176101791: MANZA BIOLOX DELTA HEAD OFFSET, 32 XL
• 00841176101784: MANZA BIOLOX DELTA HEAD OFFSET, 32 L