MANZA HEADS 103-31-030

GUDID 00841176101760

MANZA BIOLOX DELTA HEAD OFFSET, 32 S

STINSON ORTHOPEDICS INC.

Ceramic femoral head prosthesis

• Primary Device ID: 00841176101760
• NIH Device Record Key: 6b231522-5784-47d5-bbe7-6c8ec17fed6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MANZA HEADS
• Version Model Number: 103-31-030
• Catalog Number: 103-31-030
• 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	00841176101760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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