Sapphire

GUDID 00840606108317

Dia. 4.5 x 13mm Self-Tapping Fixed-Angle Screw

SPINAL ELEMENTS, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00840606108317
NIH Device Record Key17651f78-4724-488c-9c8f-ceeb200afa6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSapphire
Version Model Number27145-013
Company DUNS610712213
Company NameSPINAL ELEMENTS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com
Phone+1(760)607-0121
Emailinfo@spinalelements.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840606108317 [Primary]

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

[00840606108317]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-26
Device Publish Date2015-06-09

On-Brand Devices [Sapphire]

00840606108072Dia. 4.5 x 11mm Self-Tapping Variable-Angle Screw
00840606108065Dia. 4.5 x 10mm Self-Tapping Variable-Angle Screw
00840606108058Dia. 4.0 x 20mm Self-Tapping Variable-Angle Screw
00840606107976Dia. 4.0 x 12mm Self-Tapping Variable-Angle Screw
00840606107921Ø4.0MM x 18MM FIXED-ANGLE SELF DRILLING SCREW
008406061072042-LEVEL, 38MM ANTERIOR CERVICAL PLATE
008406061071982-LEVEL, 35MM ANTERIOR CERVICAL PLATE
008406061071812-LEVEL, 32MM ANTERIOR CERVICAL PLATE
008406061071742-LEVEL, 29MM ANTERIOR CERVICAL PLATE
008406061071672-LEVEL, 26MM ANTERIOR CERVICAL PLATE
008406061071501-LEVEL, 25MM ANTERIOR CERVICAL PLATE
008406061071431-LEVEL, 23MM ANTERIOR CERVICAL PLATE
008406061071361-LEVEL, 21MM ANTERIOR CERVICAL PLATE
008406061071291-LEVEL, 19MM ANTERIOR CERVICAL PLATE
008406061071121-LEVEL, 17MM ANTERIOR CERVICAL PLATE
008406061071051-LEVEL, 15MM ANTERIOR CERVICAL PLATE
008406061070991-LEVEL, 13MM ANTERIOR CERVICAL PLATE
008406061070821-LEVEL, 11MM ANTERIOR CERVICAL PLATE
00840606108317Dia. 4.5 x 13mm Self-Tapping Fixed-Angle Screw
00840606108300Dia. 4.5 x 12mm Self-Tapping Fixed-Angle Screw
00840606108294Dia. 4.5 x 11mm Self-Tapping Fixed-Angle Screw
00840606108287Dia. 4.5 x 10mm Self-Tapping Fixed-Angle Screw
00840606108270Dia. 4.0 x 20mm Self-Tapping Fixed-Angle Screw
00840606108263Dia. 4.0 x 19mm Self-Tapping Fixed-Angle Screw
00840606108256Dia. 4.0 x 18mm Self-Tapping Fixed-Angle Screw
00840606108249Dia. 4.0 x 17mm Self-Tapping Fixed-Angle Screw
00840606108232Dia. 4.0 x 16mm Self-Tapping Fixed-Angle Screw
00840606108225Dia. 4.0 x 15mm Self-Tapping Fixed-Angle Screw
00840606108218Dia. 4.0 x 14mm Self-Tapping Fixed-Angle Screw
00840606108201Dia. 4.0 x 13mm Self-Tapping Fixed-Angle Screw
00840606108195Dia. 4.0 x 12mm Self-Tapping Fixed-Angle Screw
00840606108171Dia. 4.0 x 10mm Self-Tapping Fixed-Angle Screw
00840606108164Dia. 4.5 x 20mm Self-Tapping Variable-Angle Screw
00840606108157Dia. 4.5 x 19mm Self-Tapping Variable-Angle Screw
00840606108140Dia. 4.5 x 18mm Self-Tapping Variable-Angle Screw
00840606108133Dia. 4.5 x 17mm Self-Tapping Variable-Angle Screw
00840606108126Dia. 4.5 x 16mm Self-Tapping Variable-Angle Screw
00840606108119Dia. 4.5 x 15mm Self-Tapping Variable-Angle Screw
00840606108102Dia. 4.5 x 14mm Self-Tapping Variable-Angle Screw
00840606108096Dia. 4.5 x 13mm Self-Tapping Variable-Angle Screw
00840606108089Dia. 4.5 x 12mm Self-Tapping Variable-Angle Screw
00840606108041Dia. 4.0 x 19mm Self-Tapping Variable-Angle Screw
00840606108034Dia. 4.0 x 18mm Self-Tapping Variable-Angle Screw
00840606108027Dia. 4.0 x 17mm Self-Tapping Variable-Angle Screw
00840606108010Dia. 4.0 x 16mm Self-Tapping Variable-Angle Screw
00840606108003Dia. 4.0 x 15mm Self-Tapping Variable-Angle Screw
00840606107990Dia. 4.0 x 14mm Self-Tapping Variable-Angle Screw
00840606107983Dia. 4.0 x 13mm Self-Tapping Variable-Angle Screw
00840606107969Dia. 4.0 x 11mm Self-Tapping Variable-Angle Screw
00840606107952Dia. 4.0 x 10mm Self-Tapping Variable-Angle Screw

Trademark Results [Sapphire]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAPPHIRE
SAPPHIRE
98616734 not registered Live/Pending
Riverview Hospital
2024-06-24
SAPPHIRE
SAPPHIRE
98534123 not registered Live/Pending
Maryam Adil LLC
2024-05-04
SAPPHIRE
SAPPHIRE
98473495 not registered Live/Pending
Sapphire Retail Limited
2024-03-28
SAPPHIRE
SAPPHIRE
98153193 not registered Live/Pending
PPC Broadband, Inc.
2023-08-28
SAPPHIRE
SAPPHIRE
98035223 not registered Live/Pending
Sapphire Healthcare LLC
2023-06-09
SAPPHIRE
SAPPHIRE
97877876 not registered Live/Pending
RETRO MANUFACTURING, L.L.C.
2023-04-07
SAPPHIRE
SAPPHIRE
97750677 not registered Live/Pending
Sapphire Systems Limited
2023-01-11
SAPPHIRE
SAPPHIRE
97745482 not registered Live/Pending
With Purpose Enterprises
2023-01-07
SAPPHIRE
SAPPHIRE
97509761 not registered Live/Pending
PPC Broadband, Inc.
2022-07-19
SAPPHIRE
SAPPHIRE
97485488 not registered Live/Pending
Michael Allen Company LLC
2022-07-01
SAPPHIRE
SAPPHIRE
97469944 not registered Live/Pending
Hefei Anchovy Information Technology Co. LTD
2022-06-22
SAPPHIRE
SAPPHIRE
97439874 not registered Live/Pending
Azer Scientific Incorporated
2022-06-02
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.