FDA.report

Proximity

Primary DI
00190376680392
Brand
Proximity
Company
ALPHATEC SPINE, INC.
Model
387-0003
Device description
Proximity Alignment Post Inserter
Published
2025-12-19
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
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications

CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions

SubmissionSupplement
K251080000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K251080000IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.2025-07-03ODP

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190376680392PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. 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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Primary DIBrandCompanyProduct codePublished
00840283404245ClariVy™VY SPINE LLCODP2026-03-19
00840283404252ClariVy™VY SPINE LLCODP2026-03-19
00840283404269ClariVy™VY SPINE LLCODP2026-03-19
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00840493416700LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
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00841193127538EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
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