MAYFIELD®
GUDID M268A11201
The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patient’s skull to hold the head and neck in a particular position during surgical procedures where rigid skeletal fixation is desired. The MAYFIELD® Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary
INTEGRA LIFESCIENCES CORPORATION
Skull clamp| Primary Device ID | M268A11201 |
| NIH Device Record Key | fa202c77-1ecf-4609-bd42-f80a4ff2dfa2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAYFIELD® |
| Version Model Number | A1120 |
| Company DUNS | 963856096 |
| Company Name | INTEGRA LIFESCIENCES CORPORATION |
| Device Count | 36 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381780253627 [Unit of Use] |
| GS1 | 10381780253624 [Primary] |
| HIBCC | M268A11201 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072208
FDA Product Code
| HBL | HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M268A11201]
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Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-09-16 |
| Device Publish Date | 2016-07-26 |
On-Brand Devices [MAYFIELD®]
| M268SGS5601 | O-RING 1/16 X 3/16" X 5/16" |
| M268SGS3191 | FOAM PAD |
| M268SGS3181 | PLASTIC BOX |
| M268S41A14361 | DISPOSABLE PIN BOX |
| M268SGS9181 | 20 PITCH SPUR GEAR |
| M268GS9181 | 20 PITCH SPUR GEAR |
| M268GS5601 | O-RING 1/16 X 3/16" X 5/16" |
| M268GS3191 | FOAM PAD |
| M268GS3181 | PLASTIC BOX |
| M26841A14361 | DISPOSABLE PIN BOX |
| M268A11221 | The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ |
| M268A11211 | The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ |
| M268A11201 | The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ |
| M268A11191 | The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ |
| M268A10841 | The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ |
| M268A10831 | The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ |
| M268A10721 | The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ |
| M268A20211 | MAYFIELD MR SKULL PIN STARTER KIT (E8806FA) |
| M268SGS1171 | O-RING 3/16" X 5/16" X 1/16" |
| M268S431A31141 | Case Label, Infinity XR2 Skull Clamp (REF A2114) (Polycarbonate) |
| M268S431A10851 | Label "A-2002" (Polyester) |
| M268S421A11231 | MAYFIELD® CLAMP SUB-ASSEMBLY |
| M268S419B12061 | MAYFIELD® Infinity Skull Clamp System Triad Rocker Arm |
| M268S419B12051 | MAYFIELD® Infinity Skull Clamp System Child Rocker Arm |
| M268S419B12041 | MAYFIELD® Infinity Skull Clamp System Adult Rocker Arm |
| M268S419A12341 | Child Rocker |
| M268S419A12091 | MAYFIELD® Infinity Skull Clamp System 80-lb Torque Screw |
| M268S419A12081 | MAYFIELD® Infinity Skull Clamp System Reduced Load 18-lb Torque Screw |
| M268S419A12071 | MAYFIELD® Infinity Skull Clamp System Single Pin Accessory |
| M268S419A12501 | MAYFIELD® Infinity Skull Clamp System Storage Case |
| M268S419A12431 | INFINITY BASE INSERT |
| M268S419A12401 | INFINITY 80 LB TORQUE KNOB |
| M268S419A12391 | INFINITY TORQUE SLEEVE |
| M268S419A12381 | 18 LB TORQUE KNOB |
| M268S419A12371 | 18 LB PISTON |
| M268S419A12361 | HANDLE BAR - INFINITY |
| M268S419A12351 | SINGLE PIN HOUSING - INFINITY |
| M268S419A12331 | PIN INSERT - INFINITY |
| M268S419A12321 | CLEVIS - INFINITY |
| M268S419A12031 | INFINITY RATCHET EXT. ASSEMBLY |
| M268GS9711 | Packing Set, A2114 Clamp |
| M268GS9701 | Transport Case |
| M268GS9381 | 6-32 SOC HD Cap SCR Stainless |
| M268GS9371 | 7/8-14 HELICAL INSERT |
| M268GS9021 | O-Ring 1.612" I.D. x .103" Thk. |
| M268GS9011 | POLYESTER FOAM CHARCOAL GRAY |
| M268GS8631 | .569" OD X .328" ID FLAT WASHER |
| M268GS8621 | CERAMIC BALLS |
| M268GS8611 | SPACER |
| M268GS8361 | FLAT HEAD SOCKET CAP SCREW |
Trademark Results [MAYFIELD]
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