FDA.report

ATEC Lateral Navigation Instruments

Primary DI
00190376494692
Brand
ATEC Lateral Navigation Instruments
Company
ALPHATEC SPINE, INC.
Model
266-00-300-N
Device description
LIF NAV PRIMARY DILATOR
Published
2023-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications

CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions

SubmissionSupplement
K223765000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223765000ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.2023-03-23OLO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190376494692PrimaryGS10

GMDN Terms

TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags

DUNS number
602465783
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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