FDA.reportPublic FDA data

Adler Instrument Company

Primary DI
00810123209736
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
39-0300
Device description
"Cloward Style Vertebra Spreader, #1 Jaw 25.5mm, open 18mm, TW 3mm (1/8""), OL 110mm (4-3/8"")"
Published
2026-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZTRetractor, Self-Retaining, For Neurosurgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071771000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071771000INSTRUMED RETRACTORSInstrumed International, Inc.2007-08-02GZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810123209736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123209736008101232097368101232097360810123209736

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8772416747orders@theadlerinstruments.com

Regulatory Flags#

DUNS number
830141235
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810220800676Adler Instrument CompanyAD13-00642026-10-28
00810220800638Adler Instrument CompanyAD50-51042026-10-15
00810220800645Adler Instrument CompanyAD11-07012026-10-15
00810220800652Adler Instrument CompanyAD30-21552026-10-15
00810220800669Adler Instrument Company30-21562026-10-15
00810220800591Adler Instrument CompanyS63882026-10-07
00810220800607Adler Instrument CompanyS63872026-10-07
00810220800614Adler Instrument CompanyS63922026-10-07
00810220800621Adler Instrument CompanyAD1211302026-10-07
00810220800577Adler Instrument Company42-02932026-09-30
00810220800584Adler Instrument CompanyAD32-110L2026-09-30
00810220800539Adler Instrument Company1682032026-08-18
00810220800546Adler Instrument Company48-51002026-08-18
00810220800553Adler Instrument Company48-01502026-08-18
00810220800508Adler Instrument CompanyAD2029-462026-07-30
00810220800515Adler Instrument CompanyADR-28092026-07-30
00810220800454Adler Instrument Company23-56152026-07-17
00810220800461Adler Instrument Company42-01742026-07-17
00810220800478Adler Instrument Company38-04702026-07-17
00810220800485Adler Instrument Company310-3832026-07-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776439736MilleniumAvalign Technologies, Inc.GZT2026-10-20
00190776434458MillenniumAvalign Technologies, Inc.GZT2026-10-07
00190776434465MillenniumAvalign Technologies, Inc.GZT2026-10-07
00810220800591Adler Instrument CompanyAdler, Inc.GZT2026-10-07
00810220800607Adler Instrument CompanyAdler, Inc.GZT2026-10-07
00810220800614Adler Instrument CompanyAdler, Inc.GZT2026-10-07
00190776420406MillenniumAvalign Technologies, Inc.GZT2026-08-26
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00724995355388V. MuellerSteris CorporationGZT2026-08-18
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